Value through Innovation27 July 2016

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Clinical Study Results

  • BUSCOPAN ® - Abdominal Pain
    Clinical Study Number 202.838
    Study Indication Abdominal Pain
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomized, double-blind, double-dummy, active-controlled, parallel-group, multicentertrial, in contrast with Hyoscine Butylbromide Capsule 10mg , to evaluate the efficacy and safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or recurrent episodes of selfreported gastric or intestinal spasm-like pain

    Study Document
    Trial synopsis 202.838_CO english
  • BUSCOPAN ® - Abdominal Pain
    Clinical Study Number 202.839
    Study Indication Abdominal Pain
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase II
    Study Title

    A double-blind, placebo controlled, randomized, parallel group study of the efficacy and tolerability of oral doses of 20 mg hyoscine butylbromide when used on demand for the treatment of self reported functional abdominal pain or discomfort associated with cramping

    Study Document
    Trial synopsis 202.839_CO english
  • BUSCOPAN® PLUS - Abdominal Pain
    Clinical Study Number 218.705
    Study Indication Abdominal Pain
    Product BUSCOPAN® PLUS
    Generic Name Hyoscine butylbromide + Paracetamol
    Lab Code
    Clinical Phase IV
    Study Title

    Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima

    Study Document
    Trial synopsis 218.705 english
  • BI 1026706 - Abdominal Pain
    Clinical Study Number 1320.22
    Study Indication Abdominal Pain
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase IIa
    Study Title

    A randomised, double-masked, placebo-controlled exploratory study to evaluate pharmacodynamics, safety, and tolerability of orally administered BI 1026706 for 12 weeks in patients with mild visual impairment due to centre-involved diabetic macular oedema (DME)

    Study Document
    Trial synopsis 1320.22 english
    Lay summary 1320.22 english
    Lay summary 1320.22 dutch
    Lay summary 1320.22 finnish
    Lay summary 1320.22 french
    Lay summary 1320.22 german
    Lay summary 1320.22 greek
    Lay summary 1320.22 hungarian
    Lay summary 1320.22 portuguese
    Lay summary 1320.22 spanish
    Lay summary 1320.22 swedish
  • VIRAMUNE ® - Acquired Immunodeficiency Syndrome
    Clinical Study Number 1100.1457
    Study Indication Acquired Immunodeficiency Syndrome
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    Clinical and therapeutic evaluation of the infection by HIV/AIDS

    Study Document
    Trial synopsis 1100.1457_CO english
  • VIRAMUNE ® - Acquired Immunodeficiency Syndrome
    Clinical Study Number 1100.1390
    Study Indication Acquired Immunodeficiency Syndrome
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    A pharmacokinetic study to evaluate the interaction between nevirapine (Viramune®) and methadone in HIV-1 infected, opioid-dependent adults on stable methadone maintenance therapy.

    Study Document
    Trial synopsis 1100.1390_CO english
  • VIRAMUNE ® - Acquired Immunodeficiency Syndrome
    Clinical Study Number 1100.1413
    Study Indication Acquired Immunodeficiency Syndrome
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase III
    Study Title

    Open-label Study evaluating the Resistance profile of Single dose Nevirapine(NVP) when combined with a 4 or 7 day course of Combivir® (ZDV)+3TC compared to Single dose Nevirapine for the Prevention of Mother to Child Transmission (pMTCT) of HIV - Treatment Options Preservation Study (T.O.P.S.)

    Study Document
    Trial synopsis 1100.1413_CO english
  • VIRAMUNE ® - Acquired Immunodeficiency Syndrome
    Clinical Study Number 1100.1414
    Study Indication Acquired Immunodeficiency Syndrome
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase IV
    Study Title

    An Open-Label Study of Nevirapine plus Combivir® (ZDV+3TC) in Women who have previously received a Nevirapine Regimen for the Prevention of Mother to Child Transmission (pMTCT) of HIV-1.

    Study Document
    Trial synopsis 1100.1414_CO english
  • Talsaclidine - Alzheimer Disease
    Clinical Study Number 506.203
    Study Indication Alzheimer Disease
    Product Talsaclidine
    Generic Name Talsaclidine
    Lab Code
    Clinical Phase IIb
    Study Title

    Efficacy and safety of 6, 12, 24, and 36 mg tid po and 36 mg bid potalsaclidine (free base) for 12 weeks in a double-blind, randomised, placebo-controlled parallel group comparison in patients with mild to moderate dementia of Alzheimer type

    Study Document
    Trial synopsis 506.203_CO english
  • Talsaclidine - Alzheimer Disease
    Clinical Study Number 506.208
    Study Indication Alzheimer Disease
    Product Talsaclidine
    Generic Name Talsaclidine
    Lab Code
    Clinical Phase IIb/III
    Study Title

    An open-label multicentre, follow-up trial to assess the long-term safety and tolerability of oral administration of talsaclidine 24mg tid in patients with mild to moderate dementia of the Alzheimer type

    Study Document
    Trial synopsis 506.208 english
  • Talsaclidine - Alzheimer Disease
    Clinical Study Number 506.209
    Study Indication Alzheimer Disease
    Product Talsaclidine
    Generic Name Talsaclidine
    Lab Code
    Clinical Phase IIb
    Study Title

    Efficacy and safety of 48 mg talsaclidine (free base) tid po (Panel1) and 60mg talsaclidine (free base) tid po (Panel2) for 12 weeks in a double­blind, randomised, placebo-controlled within escalating dose panels in 150 patients with mild to moderate dementia of Alzheimer type

    Study Document
    Trial synopsis 506.209_CO english
  • BI 409306 - Alzheimer Disease
    Clinical Study Number 1289.7
    Study Indication Alzheimer Disease
    Product BI 409306
    Generic Name BI 409306
    Lab Code BI 409306
    Clinical Phase II
    Study Title

    A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer’s Disease

    Study Document
    Trial synopsis 1289.7 english
    Lay summary 1289.7 english
    Lay summary 1289.7 dutch
    Lay summary 1289.7 french
    Lay summary 1289.7 german
    Lay summary 1289.7 italian
    Lay summary 1289.7 polish
    Lay summary 1289.7 portuguese
  • BI 409306 - Alzheimer Disease
    Clinical Study Number 1289.5
    Study Indication Alzheimer Disease
    Product BI 409306
    Generic Name BI 409306
    Lab Code BI 409306
    Clinical Phase II
    Study Title

    A multi-centre, double-blind, parallel-group, randomized controlled study to investigate the efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with Alzheimer’s Disease

    Study Document
    Trial synopsis 1289.5 english
    Lay summary 1289.5 english
    Lay summary 1289.5 dutch
    Lay summary 1289.5 french
    Lay summary 1289.5 german
    Lay summary 1289.5 italian
    Lay summary 1289.5 polish
    Lay summary 1289.5 portuguese
    Lay summary 1289.5 spanish
  • MOTENS ® - Angina Pectoris
    Clinical Study Number 231.339
    Study Indication Angina Pectoris
    Product MOTENS ®
    Generic Name Lacidipine
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, placebo-controlled, multi-centre, parallel group, dose ranging study to investigate the efficacy and safety of lacidipine in chronic stable angina. Lacidipine In Stable Angina (LISA)

    Study Document
    Trial synopsis 231.339 english
  • MOBIC ® - Arthritis, Juvenile
    Clinical Study Number 107.208
    Study Indication Arthritis, Juvenile
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase III
    Study Title

    A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis

    Study Document
    Trial synopsis 107.208_CO english
  • MOBIC ® - Arthritis, Juvenile
    Clinical Study Number 107.235
    Study Indication Arthritis, Juvenile
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase III
    Study Title

    A 12 week double-blind randomized trial, with a 12 week open-label extension, to investigate the efficacy and safety of meloxicam oral suspension administered once daily and naproxen oral suspension administered twice daily in children with Juvenile Rheumatoid Arthritis

    Study Document
    Trial synopsis 107.235_CO english
  • Amelubant - Arthritis, Rheumatoid
    Clinical Study Number 543.14
    Study Indication Arthritis, Rheumatoid
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I/IIa
    Study Title

    A double-blind, randomized, three parallel group placebo-controlled study to investigate pharmacokinetics, effect on expression of CD11b/CD18 (Mac-1), as well as safety and efficacy of two oral doses of BIIL 284 BS (dosage: 25 mg daily, 150 mg daily) in patients with rheumatoid arthritis over two weeks.

    Study Document
    Trial synopsis 543.14 english
  • Amelubant - Arthritis, Rheumatoid
    Clinical Study Number 543.27
    Study Indication Arthritis, Rheumatoid
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    Three month, randomised, double-blind, double-dummy, placebo controlled, multiple dose-range study of the efficacy and safety of BIIL284 BS (5, 25 and 75 mg p.o. once daily) in adult patients with active Rheumatoid Arthritis

    Study Document
    Trial synopsis 543.27 english
  • Doramapimod - Arthritis, Rheumatoid
    Clinical Study Number 1175.11
    Study Indication Arthritis, Rheumatoid
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, parallel, double-blind, placebo-controlled study to investigate efficacy and safety of different doses (5, 10, 20 and 30 mg) of BIRB 796 BS administered twice a day orally over 4 weeks in patients with active Rheumatoid Arthritis who have failed at least one DMARD

    Study Document
    Trial synopsis 1175.11 english
  • Doramapimod - Arthritis, Rheumatoid
    Clinical Study Number 1175.18
    Study Indication Arthritis, Rheumatoid
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase II
    Study Title

    A 12 week double-blind randomised, placebo-controlled trial to investigate efficacy, safety and pharmacokinetics of BIRB 796 BS tablets at doses of 50 and 70 mg administered twice daily in patients with active rheumatoid arthritis who have failed at least one DMARD

    Study Document
    Trial synopsis 1175.18 english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.258
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase III
    Study Title

    A Multi-Center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients with Rheumatoid Arthritis

    Study Document
    Trial synopsis 107.258_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.266
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase III
    Study Title

    A randomized, open-labelled study to compare the efficacy and safety of meloxicam 15 mg IM ampoules once daily and meloxicam 15 mg tablets administered orally once daily over a period of 7 days in patients with RA.

    Study Document
    Trial synopsis 107.266_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.267
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Meloxicam (MOBIC®) ampoule post marketing surveillance study

    Study Document
    Trial synopsis 107.267_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.245
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    COX-2 postmarketing surveillance study with MOBEC® 15 mg tablets

    Study Document
    Trial synopsis 107.245_CO english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.246
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Safety and efficacy of meloxicam (MOBIC) compared to other NSAIDs in approved therapeutic dosages and routes of administration in an observational cohort study of patients with Rheumatoid arthritis, Osteoarthritis, Lumbago, Scapulohumerla periarthritis, Neck, shoulder and arm syndrome

    Study Document
    Trial synopsis 107.246 english
  • MOBIC ® - Arthritis, Rheumatoid
    Clinical Study Number 107.249
    Study Indication Arthritis, Rheumatoid
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IV
    Study Title

    Personalized Therpeutic Experience Program (Programa de Experiencia Terapeutica Personalizada)

    Study Document
    Trial synopsis 107.249 english
  • BI 695500 - Arthritis, Rheumatoid
    Clinical Study Number 1301.1
    Study Indication Arthritis, Rheumatoid
    Product BI 695500
    Generic Name BI 695500
    Lab Code
    Clinical Phase I/III
    Study Title

    Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

    Study Document
    Trial statement 1301.1 english
    Trial synopsis 1301.1_DS english
  • BI 695500 - Arthritis, Rheumatoid
    Clinical Study Number 1301.4
    Study Indication Arthritis, Rheumatoid
    Product BI 695500
    Generic Name BI 695500
    Lab Code
    Clinical Phase III
    Study Title

    Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

    Study Document
    Trial statement 1301.4 english
    Trial synopsis 1301.4_DS english
  • CYLTEZO ® - Arthritis, Rheumatoid
    Clinical Study Number 1297.2
    Study Indication Arthritis, Rheumatoid
    Product CYLTEZO ®
    Generic Name Adalimumab-adbm
    Lab Code BI 695501
    Clinical Phase III
    Study Title

    Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

    Study Document
    Trial synopsis 1297.2 english
    Lay summary 1297.2 english
  • CYLTEZO ® - Arthritis, Rheumatoid
    Clinical Study Number 1297.11
    Study Indication Arthritis, Rheumatoid
    Product CYLTEZO ®
    Generic Name Adalimumab-adbm
    Lab Code BI 695501
    Clinical Phase II
    Study Title

    Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously with an Autoinjector in Patients with Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered with a Prefilled Syringe

    Study Document
    Trial synopsis 1297.11 english
  • CYLTEZO ® - Arthritis, Rheumatoid
    Clinical Study Number 1297.3
    Study Indication Arthritis, Rheumatoid
    Product CYLTEZO ®
    Generic Name Adalimumab-adbm
    Lab Code BI 695501
    Clinical Phase IIIb
    Study Title

    Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis: an open-label extension trial for patients who have completed Trial 1297.2 and are eligible for long-term treatment with adalimumab (VOLTAIRE-RAext)

    Study Document
    Trial synopsis 1297.3 english
  • PRADAXA ® - Arthroplasty, Replacement
    Clinical Study Number 1160.85
    Study Indication Arthroplasty, Replacement
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Observational cohort study to evaluate the safety and efficacy of Pradaxa®   (dabigatran etexilate) for the prevention of venous thromboembolism in patients  undergoing elective total hip replacement surgery or total knee replacement   surgery in a routine clinical setting

    Study Document
    Trial synopsis 1160.85_DR english
  • PRADAXA ® - Arthroplasty, Replacement
    Clinical Study Number 1160.84
    Study Indication Arthroplasty, Replacement
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Observational cohort study to evaluate the safety and efficacy of Pradaxa® (dabigatran etexilate) in patients with moderate renal impairment (creatinine clearance 30-50 mL/min) undergoing elective total hip replacement surgery or total knee replacement surgery

    Study Document
    Trial synopsis 1160.84_DR english
  • PRADAXA ® - Arthroplasty, Replacement
    Clinical Study Number 1160.118
    Study Indication Arthroplasty, Replacement
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Observational cohort study to evaluate the safety and efficacy of switching from Lovenox® (enoxaparin) 40 mg to Pradaxa® (dabigatran etexilate) 220 mg in patients undergoing elective total hip or knee replacement surgery

    Study Document
    Trial synopsis 1160.118_DR english
    Trial statement 1160.118_DR english
  • PRADAXA ® - Arthroplasty, Replacement, Knee
    Clinical Study Number 1160.25
    Study Indication Arthroplasty, Replacement, Knee
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 8 ±2 days, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery.RE-MODEL (Thromboembolism prevention after knee surgery)

    Study Document
    Trial synopsis 1160.25_DR english
  • PRADAXA ® - Arthroplasty, Replacement, Knee
    Clinical Study Number 1160.50
    Study Indication Arthroplasty, Replacement, Knee
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, parallel-group, double-blind, placebo controlled study to investigate the efficacy and safety of BIBR 1048 in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery

    Study Document
    Trial synopsis 1160.50_DS_CO english
  • PRADAXA ® - Arthroplasty, Replacement, Knee
    Clinical Study Number 1160.24
    Study Indication Arthroplasty, Replacement, Knee
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III, randomized, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens (75mg Day 1 followed by 150 mg Day 2-completion, and 110 mg Day 1 followed by 220 mg Day 2-completion) of dabigatran etexilate administered orally (capsules), compared to enoxaparin 30 mg twicea day subcutaneous for 12-15 days in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery

    Study Document
    Trial synopsis 1160.24_DS_CO english
  • PRADAXA ® - Arthroplasty, Replacement, Knee
    Clinical Study Number 1160.86
    Study Indication Arthroplasty, Replacement, Knee
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    An open label, non-comparative, pharmacokinetic and pharmacodynamic study to evaluate the effect of Dabigatran Etexilate on coagulation parameters including a calibrated thrombin time test in patients with moderate renal impairment (creatinine clearance 30-50 mL/min) undergoing primary unilateral elective total knee or hip replacement surgery

    Study Document
    Trial synopsis 1160.86_DR english
  • ATROVENT ® - Asthma
    Clinical Study Number 244.2413
    Study Indication Asthma
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Double-blind, controlled trial to assess the efficacy of ipratropium bromide associated with high dose salbutamol by repeated nebulisation versus repeated nebulisation of salbutamol alone, for 120 minutes, in acute asthmatic attacks in young children.

    Study Document
    Trial synopsis 244.2413_CO english
  • Amelubant - Asthma
    Clinical Study Number 543.11
    Study Indication Asthma
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    The effect BIIL 284 BS ( 14 day treatment) on induced-sputum variables in patients with bronchial asthma (a double-blind. randomized, placebo-controlled parallel study)

    Study Document
    Trial synopsis 543.11_CO english
  • BERODUAL ® - Asthma
    Clinical Study Number 215.1104
    Study Indication Asthma
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase III
    Study Title

    Comparison of the safety and efficacy of Berodual® administered via Respimat® device (50 mcg fenoterol hydrobromide/20 mcg ipratropium bromide and 25 mcg fenoterol hydrobromide/10 mcg ipratropium bromide, 1 puff q.i.d.) with that administered via the MDI (50 mcg fenoterol hydrobromide/21 mcg ipratropium bromide, 2 puffs q.i.d.) in asthma patients over a 12-week period.

    Study Document
    Trial synopsis 215.1104 english
  • BERODUAL ® - Asthma
    Clinical Study Number 215.1105
    Study Indication Asthma
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind study to compare the safety and efficacy of Berodual® inhaled via the Respimat® device in two dosages (50 µg fenoterol hydrobromide + 20 µg ipratropium bromide and 25 µg fenoterol hydrobromide + 10 µg ipratropium bromide, 1 puff t.i.d) with that of Berodual® inhaled via the Chlorofluorocarbons (CFC)-metered dose inhaler (MDI) with Aerochamber® (50 µg fenoterol hydrobromide + 21 µg ipratropium bromide, 2 puffs t.i.d.) in paediatric patients with asthma over a 4 week period

    Study Document
    Trial synopsis 215.1105 english
  • BI 54903 - Asthma
    Clinical Study Number 1248.5
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 22.7, 45.5 and 90.9 µg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 88 µg b.i.d. in patients with asthma inadequately controlled on SABA therapy

    Study Document
    Trial statement 1248.5_DR english
    Trial synopsis 1248.5_6_7_DR english
  • BI 54903 - Asthma
    Clinical Study Number 1248.6
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 45.5, 90.9 and 181.8 µg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 220 µg b.i.d. in patients with asthma inadequately controlled on low dose ICS therapy

    Study Document
    Trial statement 1248.6_DR english
    Trial synopsis 1248.5_6_7_DR english
  • BI 54903 - Asthma
    Clinical Study Number 1248.7
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, double-dummy, active-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 90.9, 181.8 and 363.6 µg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 440 µg b.i.d. in patients with asthma inadequately controlled on medium dose ICS therapy

    Study Document
    Trial statement 1248.7_DR english
    Trial synopsis 1248.5_6_7_DR english
  • BI 54903 - Asthma
    Clinical Study Number 1249.7
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIa
    Study Title

    A single dose, placebo-controlled, randomised, double-blind double dummy, 5-way crossover (7 treatments, 5 periods incomplete block), including 24-h pulmonary function tests, pharmacodynamic comparison of olodaterol/BI 54903 fixed dose combination inhalation solutions via Respimat® (including clinical doses of 1.23/363.6 µg, 2.46/363.6 µg and 4.93/363.6 µg) versus free combinations of olodaterol inhalation solutions (0, 2.5µg, 5 µg and 10 µg) via Respimat® plus BI 54903 inhalation solution (363.6 µg ) in patients with asthma.

    Study Document
    Trial statement 1249.7_DR english
  • BI 54903 - Asthma
    Clinical Study Number 1256.13
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase Ib
    Study Title

    Serial lung function measurements in 12 healthy and 48 mild asthmatic adults after oral inhalation of ethanolic solutions containing two concentrations of the excipient butylated hydroxytoluene (BHT, 0.1% and 0.5%) administered with the Respimat® B (RMT-B) vs. corresponding RMT-B and HFA MDI without BHT; repeated increasing doses with 2, 4, and 6 actuations of low concentration prior to high concentration on separate days, double blind for RMT-B use, randomised 4-way cross-over design

    Study Document
    Trial synopsis 1256.13_CO english
  • BI 671800 - Asthma
    Clinical Study Number 1268.16
    Study Indication Asthma
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of 6 weeks of oral BI 671800 ED 400 mg b.i.d., Montelukast 10 mg q.d., or placebo in symptomatic asthma patients on fluticasone propionate MDI

    Study Document
    Trial synopsis 1268.16 english
  • BI 671800 - Asthma
    Clinical Study Number 1268.53
    Study Indication Asthma
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, double-blind, placebo-controlled, efficacy and safety cross-over study of 4 weeks of oral BI 671800 ED 200 mg twice daily or 400 mg once daily administered in the morning (AM) or evening (PM), in symptomatic asthma patients on inhaled fluticasone propionate MDI

    Study Document
    Trial synopsis 1268.53_DR english
  • BI 671800 - Asthma
    Clinical Study Number 1268.17
    Study Indication Asthma
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomized, double blind, placebo and active controlled, parallel group study to evaluate the safety and efficacy of 6-week treatment with oral doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in steroid-naive patients with persistent asthma

    Study Document
    Trial synopsis 1268.17_DR english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.50
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IIb
    Study Title

    A single dose randomized, double-blind crossover comparison of COMBIVENT® CFC MDI and albuterol HFA MDI in patients with moderate to severe persistent asthma and persistent symptoms despite treatment with inhaled corticosteroids

    Study Document
    Trial synopsis 1012.50_CO english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.57
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase II
    Study Title

    A multicenter, randomized study starting with a 4-week, 2-way crossover double-blind treatment phase comparing the efficacy and safety of Combivent® CFC MDI to albuterol HFA MDI followed by a 4-week open-label Combivent® Respimat® treatment phase when all study drugs are used for symptom relief “as needed” in patients with moderate-to-severe asthma (GINA 2007 Treatment Steps 3-5)

    Study Document
    Trial synopsis 1012.57_DS_CO english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.32
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase III
    Study Title

    Open Study on the Efficacy and Safety of CombiVent® Aerosol (120 mcg Salbutamol sulfate+ 20 mcg ipratropimm bromide)+ Spacer, 12 to24 puffs, in adult patients with moderate-to-severe asthma crisis

    Study Document
    Trial synopsis 1012.32_CO english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.36
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IV
    Study Title

    COMBIVENT vs. SALBUTAMOL in patients with metacholine-induced bronchospasm.

    Study Document
    Trial synopsis 1012.36_CO english
  • INFLAMMIDE ® - Asthma
    Clinical Study Number 1047.16
    Study Indication Asthma
    Product INFLAMMIDE ®
    Generic Name Budesonide
    Lab Code
    Clinical Phase IIIa
    Study Title

    A Randomised Double-Blind, Double-Dummy, Parallel Group Design.Twelve-week, Efficacy and Safety Study Comparing Respimat ® Budesonide (100 and 200 mcg, 2 puffs bid) with Turbohaler® Budesonide (200 mcg, 2 puffs bid) in Symptomatic Adult Moderate to Severe Asthmatics Requiring Inhaled Corticosteroids and Bronchodilator Therapy.

    Study Document
    Trial synopsis 1047.16 english
  • OXIVENT ® - Asthma
    Clinical Study Number 54.562
    Study Indication Asthma
    Product OXIVENT ®
    Generic Name Oxitropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A phase III long-term study of Ba253BINEB in patients with bronchial asthma.

    Study Document
    Trial synopsis 54.562 english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.341
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II A
    Study Title

    A Randomised, Double-Blind, Placebo-Controlled, Crossover Efficacy and Safety Evaluation of 8-Week Treatment Periods of Two Doses [5 mcg (2 actuations of 2.5 mcg) and 10 mcg (2 actuations of 5 mcg)] of Tiotropium Inhalation Solution Delivered by the Respimat® Inhaler as Add-on Therapy in Patients with severe persistent Asthma

    Study Document
    Trial synopsis 205.341_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.342
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIa
    Study Title

    A 16-week randomised, placebo-controlled, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of tiotropium inhalation solution delivered by the Respimat® inhaler (2 puffs of 2.5 µg once daily) with that of salmeterol from the hydrofluoroalkane metered dose inhaler (2 puffs of 25 µg twice daily) in moderate persistent asthma patients homozygous for B16-Arg/Arg

    Study Document
    Trial synopsis 205.342_DS_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.424
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II randomised, double-blind, placebo-controlled, incomplete crossover trial with 4-week treatment periods to evaluate efficacy and safety of tiotropium inhalation solution (doses of 1.25 µg, 2.5 µg and 5 µg) delivered via Respimat® inhaler once daily in the evening in adolescents (12 to 17 yrs old) with moderate persistent asthma

    Study Document
    Trial synopsis 205.424_DS_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.417
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIa
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma

    Study Document
    Trial synopsis 205.417_DS_DR english
    Combined analysis 205.416_205.417_DS_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.416
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIa
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma

    Study Document
    Trial synopsis 205.416_DS_DR english
    Combined analysis 205.416_205.417_DS_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.420
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II, randomised, double-blind, placebo controlled, crossover efficacy and   safety comparison of tiotropium 5 µg administered once daily (in the evening)   and tiotropium 2.5 µg administered twice daily delivered by the Respimat®   inhaler for four weeks versus placebo in patients with moderate persistent   asthma

    Study Document
    Trial synopsis 205.420_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.380
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II randomised, double-blind, placebo controlled, crossover efficacy and safety comparison of three doses of tiotropium inhalation solution delivered via Respimat® inhaler (1.25, 2.5, and 5 µg once daily) versus placebo in patients with moderate persistent asthma

    Study Document
    Trial synopsis 205.380_DS_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.442
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III, randomised, double-blind, placebo-controlled, parallel-group trial to   evaluate efficacy and safety of tiotropium inhalation solution delivered via   Respimat® inhaler (2.5 µg and 5 µg once daily) compared to placebo over 12 weeks in mild persistent asthma

    Study Document
    Trial synopsis 205.442_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.425
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A phase II randomised, double-blind, placebo-controlled incomplete crossover trial with 4-week treatment periods to evaluate efficacy and safety of tiotropium inhalation solution (doses of 1.25 µg, 2.5 µg, and 5 µg) delivered via Respimat® inhaler once daily in the evening in children 6 to 11 years old with moderate persistent asthma

    Study Document
    Trial synopsis 205.425_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.418
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to   evaluate efficacy and safety of tiotropium inhalation solution delivered via  Respimat® inhaler (2.5 and 5 µg once daily) compared with placebo and  salmeterol HFA MDI (50 µg twice daily) over 24 weeks in patients with moderate persistent asthma

    Study Document
    Trial synopsis 205.418_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.419
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to   evaluate efficacy and safety of tiotropium inhalation solution delivered via  Respimat® inhaler (2.5 and 5 µg once daily) compared with placebo and  salmeterol HFA MDI (50 µg twice daily) over 24 weeks in patients with moderate persistent asthma

    Study Document
    Trial synopsis 205.419_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.464
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate safety and efficacy of tiotropium inhalation solution delivered via Respimat inhaler (2.5 and 5 µg once daily) compared with placebo over 52 weeks in patients with moderate to severe persistent asthma

    Study Document
    Trial synopsis 205.464_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.444
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double blind, placebo-controlled, parallel group study to assess the efficacy and safety over 48 weeks of orally inhaled Tiotropium bromide (2.5 and 5 µg once daily ) delivered by the Respimat® inhaler in adolescents (12 to 17 years old) with moderate persistent asthma.

    Study Document
    Trial synopsis 205.444_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.441
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, double- blind, 2 way cross-over study to determine 24-hour FEV1-time profile of inhaled tiotropium, delivered via the Respimat inhaler, after 4 weeks of once daily [5 mcg in the evening (2 actuations of 2.5 mcg)] or twice daily [2.5 mcg in the morning and evening (2 actuations of 1.25 mcg)] administration in patients with moderate persistent asthma.

    Study Document
    Trial synopsis 205.441_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.456
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma

    Study Document
    Trial synopsis 205.456_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.443
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II/III
    Study Title

    A phase II/III, randomised, double-blind, placebo-controlled, parallel group trialto evaluate safety and efficacy of tiotropium inhalation solution (2.5 µg and5 µg) administered once daily in the afternoon via Respimat® Inhaler for12 weeks in patients 1 to 5 years old with persistent asthma

    Study Document
    Trial synopsis 205.443_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.446
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution (2.5 µg and 5 µg) delivered via Respimat® inhaler once daily in the evening over 12 weeks as add-oncontroller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma

    Study Document
    Trial synopsis 205.446_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.445
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 48 weeks in children (6 to 11 years old) with moderate persistent asthma

    Study Document
    Trial synopsis 205.445_DR english
    Lay summary 205.445 english
    Lay summary 205.445 german
  • STRIVERDI ® - Asthma
    Clinical Study Number 1222.4
    Study Indication Asthma
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, double-blind, placebo-controlled, 5-way cross-over study to assess   the efficacy (Bronchoprotection) and safety of a single dose of orally inhaled BI 1744 CL (2 µg, 5 µg, 10 µg, 20 µg) in patients with intermittent asthma

    Study Document
    Trial synopsis 1222.4_DS_CO english
  • STRIVERDI ® - Asthma
    Clinical Study Number 1222.6
    Study Indication Asthma
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    Randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy (bronchodilation) and safety of 4 weeks of once daily treatment of orally  inhaled BI 1744 CL (2 µg, 5 µg, 10 µg, 20_µg) delivered by the Respimat® inhaler in patients with asthma

    Study Document
    Trial synopsis 1222.6_DR english
  • STRIVERDI ® - Asthma
    Clinical Study Number 1222.27
    Study Indication Asthma
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    A Randomised, Double-Blind, Placebo- and Active-Controlled, Incomplete Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Once Daily Treatment of 4 Doses of BI 1744 CL Inhalation Solution Delivered by the Respimat® in Patients with Asthma

    Study Document
    Trial synopsis 1222.27_DR english
  • STRIVERDI ® - Asthma
    Clinical Study Number 1222.29
    Study Indication Asthma
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    Phase II, Randomised, Double-Blind, Cross-over Study to Compare the 24-hour FEV1-time Profile of Orally Inhaled Olodaterol, delivered with the Respimat® Inhaler, after 3 Weeks of Olodaterol Once Daily 5 µg [2 actuations of 2.5 µg], Twice Daily 2.5 µg [2 actuations of 1.25 µg] and Placebo or after 3 Weeks of Once Daily 10 µg [2 actuations of 5 µg], Twice Daily 5 µg [2 actuations of 2.5 µg] and Placebo Administration in Patients with Moderate to Severe Persistent Asthma

    Study Document
    Trial synopsis 1222.29_DR english
  • n/a - Healthy , Asthma
    Clinical Study Number 352.2087
    Study Indication Healthy ; Asthma
    Product n/a
    Generic Name n/a
    Lab Code n/a
    Clinical Phase n/a
    Study Title

    An exploratory, prospective, non-interventional study comparing biomarker signatures between patients with asthma and healthy volunteers and to investigate biomarkers associated with known phenotypes across asthma severities

    Study Document
    Trial synopsis 352.2087 english
  • Tiotropium + BI 54903 - Asthma
    Clinical Study Number 1298.3
    Study Indication Asthma
    Product Tiotropium + BI 54903
    Generic Name Tiotropium + BI 54903
    Lab Code
    Clinical Phase II
    Study Title

    A single dose, randomised, placebo-controlled, double-blind, 5-way crossover (employing an incomplete block design), efficacy (including 24-h pulmonary function tests) and safety comparison of Tiotropium/BI 54903 FDC ethanolic inhalation solution via Respimat® (doses of 1.23 μg/363.6 μg, 2.46 μg/363.6 μg or 4.93 μg/363.6 μg) versus free combination of Tiotropium aqueous inhalation solution via Respimat® (doses of 0, 2.5 μg, 5 μg or 10 μg) plus BI 54903 ethanolic inhalation solution via Respimat® (dose of 363.6 μg ) in patients with asthma

    Study Document
    Trial statement 1298.3 english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.525
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Specific Use-Result Surveillance of Spiriva Respimat in Asthmatics (patients with severe persistent asthma)

    Study Document
    Trial synopsis 205.525 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.128
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    A prospective, open label study evaluating the efficacy of two management strategies (pantoprazole 40 mg q.a.m. and taking Pradaxa® with food (within 30 minutes after a meal) on gastrointestinal symptoms (GIS) in patients newly on treatment with Pradaxa® 150 mg b.i.d., 110 mg b.i.d. or 75 mg b.i.d. for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF)

    Study Document
    Trial synopsis 1160.128_DR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.26
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    Randomized Evaluation of Long term anticoagulant therapY (RE-LY®) comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial (RE-LY® study)

    Study Document
    Trial synopsis 1160.26_DR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.20
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

    Prevention of Embolic and Thrombotic Events in Patients with Persistent Atrial Fibrillation. A Dose Exploration Study of BIBR 1048, an Oral Direct Thrombin Inhibitor, with and without Concomitant Acetylsalicylic Acid, in Comparison to Warfarin (PETRO)

    Study Document
    Trial synopsis 1160.20_DS_CO english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.42
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

    Long-term, open-label follow-up treatment of patients with atrial fibrillation who have been previously treated with BIBR 1048 in the PETRO trial (Trial 1160.20). (PETRO Extension trial: PETRO-Ex)

    Study Document
    Trial synopsis 1160.42_DS_CO english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.49
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

    Open label, randomised exploratory dose response study in pharmacodynamics and safety of BIBR 1048 (110 mg b.i.d. and 150 mg b.i.d.) for 12 weeks in patients with non-valvular atrial fibrillation in comparison to warfarin

    Study Document
    Trial synopsis 1160.49_DS_CO english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.71
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIIb
    Study Title

    RELY-ABLE long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial and a cluster randomised trial to assess the effect of a knowledge translation intervention on patient outcomes

    Study Document
    Trial synopsis 1160.71_DR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.114
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients with Atrial Fibrillation (Phase I)

    Study Document
    Trial synopsis 1160.114_DR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.157
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Comparative effectiveness of oral anticoagulants: A cohort study

    Study Document
    Trial synopsis 1160.157_CO english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.170
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Use of Pradaxa® (dabigatran etexilate) for stroke prevention in patients with non valvular atrial fibrillation and mild to moderate renal impairment

    Study Document
    Trial synopsis 1160.170_CO english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.183
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    The Comparative Safety and Effectiveness of Dabigatran and Warfarin Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation Patient Population - A Retrospective Database Analysis

    Study Document
    Trial synopsis 1160.183_DR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.149
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Post-authorisation study to evaluate the effectiveness of the risk minimisation activities in the treatment of SPAF

    Study Document
    Trial synopsis 1160.149_DR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.173
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    A prospective, open label study to evaluate the pharmacokinetics of dabigatran in non-valvular atrial fibrillation (NVAF) patients with severely impaired renal function on dabigatran etexilate 75 mg BID therapy

    Study Document
    Trial synopsis 1160.173_DR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.162
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    An observational study assessing the management of gastrointestinal and urogenital bleeding events in patients with non valvular atrial fibrillation treated with dabigatran etexilate

    Study Document
    Trial synopsis 1160.162 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.192
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Humana Non-Valvular Atrial Fibrillation Patient Population – A Retrospective Database Analysis

    Study Document
    Trial synopsis 1160.192_PR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.263
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Engel 2: REal-life aNticoaGulants comparative bEnefit-risk in nonvalvular atrial fibrilLation (NVAF) in France

    Study Document
    Trial synopsis 1160.263_PR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.144
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Evaluation of potential off-label use of dabigatran etexilate in Europe

    Study Document
    Trial synopsis 1160.144 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.130
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation

    Study Document
    Trial Synopsis 1160.130 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.254
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Comparison of the length of stay in patients hospitalized and initiated with dabigatran or warfarin for a concomitant Non-Valvular Atrial Fibrillation in real-world Japanese therapeutic practice (SHORT-J)

    Study Document
    Trial synopsis 1160.254 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.204
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Randomised Evaluation of dabigatran etexilate Compared to warfarIn in pulmonaRy vein ablation: assessment of an uninterrupted periproCedUral antIcoagulation sTrategy (The RE-CIRCUIT Trial)

    Study Document
    Trial synopsis 1160.204 english
    Lay summary 1160.204 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160-0279
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Treatment patterns of newly initiated oral anticoagulants on Japanese nonvalvular atrial fibrillation patients using a Japanese claims database

    Study Document
    Trial synopsis 1160-0279 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.200
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    A retrospective cohort study with chart review to assess the management of major bleeding events in non-valvular atrial fibrillation (NVAF) patients treated with dabigatran etexilate

    Study Document
    Trial synopsis 1160.200 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.247
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa® or Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation

    Study Document
    Trial synopsis 1160.247_PR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.186
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIIb
    Study Title

    A prospective Randomised, open label, blinded endpoint (PROBE) study to Evaluate DUAL antithrombotic therapy with dabigatran etexilate (110 mg and 150 mg b.i.d.) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0 – 3.0) plus clopidogrel or ticagrelor and aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting (RE-DUAL PCI)

    Study Document
    Trial synopsis 1160.186 english
    Lay summary 1160.186 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.219
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Association of select EMR-based covariates with oral anticoagulant medication selection

    Study Document
    Trial synopsis 1160.219_PR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.249
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa® or Vitamin K Antagonist (VKA) for Stroke Prophylaxis in Atrial Fibrillation.

    Study Document
    Trial synopsis 1160.249 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.274
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    The Comparative Safety and Effectiveness of Dabigatran, versus Rivaroxaban, and Apixaban Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis

    Study Document
    Trial synopsis 1160.274 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.177
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    A description of warfarin and new oral anticoagulant utilization patterns including initiation, switching, and discontinuation: Phase 3 of the BI/BWH Pradaxa study program

    Study Document
    Trial synopsis 1160.177 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.207
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Sequential expansion of comparative effectiveness of oral anticoagulants: A cohort study

    Study Document
    Trial synopsis 1160.207 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160-0288
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Comparative Effectiveness and Safety between Warfarin and Dabigatran Using Real World Claims data of Japanese Non-valvular Atrial Fibrillation Patients

    Study Document
    Trial synopsis 1160-0288 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.261
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Non-interventional study describing patients’ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa® or vitamin K antagonist for stroke prophylaxis in atrial fibrillation

    Study Document
    Trial synopsis 1160.261 english
  • PRAXBIND ® - Atrial Fibrillation
    Clinical Study Number 1160.218
    Study Indication Atrial Fibrillation
    Product PRAXBIND ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    AVANTI: Drug persistence/adherence in patients being treated with Pradaxa® (dabigatran etexilate) or vitamin K antagonists (VKA) for stroke prevention in non-valvular atrial fibrillation (AF).

    Study Document
    Trial synopsis 1160.218 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160-0280
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Non-Interventional, cross-sectional study to describe healthrelated quality of life among controlled and uncontrolled patients with nonvalvular atrial fibrillation on anticoagulants. RE-QUOL study.

    Study Document
    Trial synopsis 1160-0280 english
  • Bivatuzumab - Breast Neoplasms
    Clinical Study Number 1170.2
    Study Indication Breast Neoplasms
    Product Bivatuzumab
    Generic Name Bivatuzumab
    Lab Code
    Clinical Phase I
    Study Title

    A phase I biodistribution study with 186 Re-labelled humanised monoclonal antibody BIWA 4, in patients with adenocarcinoma of the breast.

    Study Document
    Trial synopsis 1170.2_CO english
  • Bivatuzumab - Breast Neoplasms
    Clinical Study Number 1191.1
    Study Indication Breast Neoplasms
    Product Bivatuzumab
    Generic Name Bivatuzumab
    Lab Code
    Clinical Phase I
    Study Title

    An open phase I single dose escalation study of bivatuzumab mertansine administered intravenously in female patients with CD44v6 positive metastatic breast cancer with repeated administration in patients with clinical benefit

    Study Document
    Trial synopsis 1191.1 english
  • Bivatuzumab - Breast Neoplasms
    Clinical Study Number 1191.3
    Study Indication Breast Neoplasms
    Product Bivatuzumab
    Generic Name Bivatuzumab
    Lab Code
    Clinical Phase I
    Study Title

    An open phase I dose escalation study of bivatuzumab mertansine administered intravenously once per week for three weeks in female patients with CD44v6 positive recurrent or metastatic breast cancer with repeated administration courses in patients with clinical benefit

    Study Document
    Trial synopsis 1191.3 english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.5
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A phase II study of BIBW 2992 added to letrozole in patients with ER+ve   hormone refractory metastatic breast cancer progressing on letrozole

    Study Document
    Trial synopsis 1200.5_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.10
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    An open-label phase II trial to assess the efficacy and safety of a once daily oral   dose of 50 mg BIBW 2992 in two cohorts of patients with HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen

    Study Document
    Trial synopsis 1200.10 english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.11
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    Phase II trial of BIBW 2992 in patients with HER2-positive metastatic breast cancer after failure of trastuzumab therapy

    Study Document
    Trial synopsis 1200.11_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.44
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A neoadjuvant, randomized, open-label Phase II trial of BIBW 2992 versus  trastuzumab versus lapatinib in patients with locally advanced HER2 –positive  breast cancer

    Study Document
    Trial synopsis 1200.44_DS_CO english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.68
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I open label trial to assess safety of BIBW 2992 in combination with Herceptin® in patients with HER2-positive advanced breast cancer

    Study Document
    Trial synopsis 1200.68_CO english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.75
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Breast 1; An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment

    Study Document
    Trial synopsis 1200.75_CO english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.67
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    LUX-Breast 3; Randomised phase II study of afatinib alone or in combination with vinorelbine versus investigator’s choice of treatment in patients with HER2-positive breast cancer with progressive brain metastases after trastuzumab and/or lapatinib based therapy

    Study Document
    Trial synopsis 1200.67_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.89
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    An open label, phase II trial of afatinib with or without vinorelbine for the treatment of HER2-overexpressing inflammatory breast cancer

    Study Document
    Trial snyopsis 1200.89_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.134
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I trial of afatinib in combination with 3 weekly trastuzumab in patients with tumours overexpressing HER2. Once the MTD of afatinib with 3 weekly trastuzumab was established the safety of this dose will be assessed also in combination with weekly trastuzumab

    Study Document
    Trial statement 1200.134 english
    Trial synopsis 1200.134 english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.98
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    LUX-Breast 2: An open-label, phase II trial of BIBW 2992 (afatinib) in patients with metastatic HER2-overexpressing breast cancer failing HER2- targeted treatment in the neoadjuvant and/or adjuvant treatment setting

    Study Document
    Trial synopsis 1200.98 english
  • MYCLO ® - Candidiasis, Oral
    Clinical Study Number 1190.1
    Study Indication Candidiasis, Oral
    Product MYCLO ®
    Generic Name Clotrimazole
    Lab Code
    Clinical Phase III
    Study Title

    A Prospectively Randomized, Blinded, Parallel Group Study of Clotrimazole Troches vs. Mycelex® Troches (10 mg troche five times a day for 14 days) in Patients With Human Immunodeficiency VIrus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis

    Study Document
    Trial synopsis 1190.1_CO english
  • VARGATEF ® - Carcinoma, Hepatocellular
    Clinical Study Number 1199.39
    Study Indication Carcinoma, Hepatocellular
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    A multicenter, open label, phase I/randomized II study to evaluate safety, pharmacokinetics and efficacy of BIBF 1120 in comparison with sorafenib for advanced hepatocellular carcinoma patients in Asia.

    Study Document
    Trial synopsis 1199.39 english
  • VARGATEF ® - Carcinoma, Hepatocellular
    Clinical Study Number 1199.37
    Study Indication Carcinoma, Hepatocellular
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    A multicentre, open label, Phase I/randomised Phase II study to evaluate safety, pharmacokinetics and efficacy of BIBF 1120 in comparison with sorafenib for advanced hepatocellular carcinoma patients

    Study Document
    Trial synopsis 1199.37 english
  • VARGATEF ® - Carcinoma, Hepatocellular
    Clinical Study Number 1199.120
    Study Indication Carcinoma, Hepatocellular
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    An open label, dose escalation phase I study to evaluate the safety and tolerability of continuous twice-daily oral treatment of nintedanib in Japanese patients with hepatocellular carcinoma

    Study Document
    Trial synopsis 1199.120_DR english
  • BI 2536 - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1216.5
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open-label dose escalation study of intravenous BI 2536 together with pemetrexed in previously treated patients with non-small-cell lung cancer

    Study Document
    Trial synopsis 1216.5_CO english
  • BI 2536 - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1216.9
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase II
    Study Title

    An open, randomised clinical Phase II trial to investigate the efficacy, safety and pharmacokinetics of a single dose of 200 mg of i.v. BI 2536 in comparison to 50 mg of i.v. BI 2536 administered on days 1, 2 and 3 in patients with advanced or metastatic non small cell lung cancer

    Study Document
    Trial synopsis 1216.9_CO english
  • Bivatuzumab - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1170.3
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product Bivatuzumab
    Generic Name Bivatuzumab
    Lab Code
    Clinical Phase I
    Study Title

    A phase I biodistribution study with 186 Re-labelled humanised monoclonal antibody BIWA 4, in patients with non-small cell lung cancer.

    Study Document
    Trial synopsis 1170.3_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.22
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    LUX Lung 2: A Phase II single arm trial of BIBW 2992 in non-small cell lung cancer patients with EGFR activating mutations

    Study Document
    Trial synopsis 1200.22_PE_DS_CO english
    Trial synopsis 1200.22_DS_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.23
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIb/III
    Study Title

    Phase IIb/III randomised, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib (LUX-Lung 1)

    Study Document
    Trial snopsis 1200.23_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.32
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Lung 3; A randomised, open-label, phase III study of BIBW 2992 versus chemotherapy as first-line treatment for patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR-activating mutation

    Study Document
    Trial synopsis 1200.32 english
    Lay summary 1200.32 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.33
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I/II
    Study Title

    LUX-Lung 4: A Phase I/II open label trial of continuous once daily oral treatment with BIBW 2992 – Phase I trial in advanced non small cell lung cancer patients & Phase II trial in non small cell lung cancer patients failing erlotinib or gefitinib – Full Analysis for Phase I. LUX-Lung 4: A Phase I/II open label trial of continuous once daily oraltreatment with BIBW 2992 – Phase I trial in advanced non small cell lung cancerpatients & Phase II trial in non small cell lung cancer patients failing erlotinib orgefitinib – Full Analysis for Phase II

    Study Document
    Trial synopsis 1200.33_Ph_1_DS_CO english
    Trial synopsis 1200.33_Ph_2_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.41
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II single-arm trial of BIBW 2992 in demographically and genotypically selected non-small cell lung cancer patients

    Study Document
    Trial synopsis 1200.41_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.72
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II trial of BIBW 2992 as a third-line treatment for patients with stage IIIB/IV adenocarcinoma of the lung harbouring wild-type EGFR

    Study Document
    Trial synopsis 1200.72_DS_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.40
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A phase II single-arm trial of BIBW 2992 in EGFR FISH positive non-small cell lung cancer patients

    Study Document
    Trial synopsis 1200.40_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.34
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Lung 6: A randomised, open-label, phase III study of BIBW 2992 versus chemotherapy as first-line treatment for patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR-activating mutation

    Study Document
    Trial synopsis 1200.34 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.71
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase Ib open-label clinical trial of continuous once daily oral treatment using BIBW 2992 plus cetuximab (Erbitux®) in patients with non-small cell lung cancer with progression following prior erlotinib (Tarceva®) or gefitinib (Iressa®)

    Study Document
    Trial synopsis 1200.71_PE_DR english
    Trial synopsis 1200.71_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.42
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    Phase III randomized trial of BIBW 2992 plus weekly paclitaxel versus Investigator's choice of chemotherapy following BIBW 2992 monotherapy in non-small cell lung cancer patients failing previous erlotinib or gefitinib treatment (LUX lung 5)

    Study Document
    Trial synopsis 1200.42_OS english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.70
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase Ib open-label clinical trial of continuous once daily oral treatment using BIBW 2992 plus sirolimus in patients with non-small cell lung cancer harbouring an EGFR mutation and/or disease progression following prior erlotinib or gefitinib

    Study Document
    Trial synopsis 1200.70 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.125
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Lung 8: A randomized, open-label phase III trial of afatinib versus erlotinib in patients with advanced squamous cell carcinoma of the lung as second-line therapy following first-line platinum-based chemotherapy

    Study Document
    Lay summary 1200.125_OS english
    Trial synopsis 1200.125 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.167
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Phase IIIb, non-randomized, open-label, two-cohort study in patients with EGFR mutations-positive advanced adenocarcinoma of the lung, assessing the utility of the Afatinib Diarrhea Assessment and Management guidelines (ADAM)

    Study Document
    Trial synopsis 1200.167_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.121
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase 1b study of intermittent administration of high doses of the irreversible EGFR inhibitor afatinib as a means of achieving plasma levels active against non-small cell lung cancer with known T790M mutations

    Study Document
    Trial synopsis 1200.121_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.123
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIb
    Study Title

    LUX-Lung 7: A randomised, open-label Phase IIb Trial of afatinib versus gefitinib as first-line treatment of patients with EGFR mutation positive advanced adenocarcinoma of the lung

    Study Document
    Lay summary 1200.123_primary_analysis english
    Lay summary 1200.123_overall_survival english
    Trial synopsis 1200.123 primary analysis english
    Trial synopsis 1200.123 overall survival english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.29
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I study of continuous, concomitant oral treatment with BIBF 1120 and docetaxel - a Phase I, open-label, dose-escalation study in Japanese patients with stage IIIB/IV or recurrent non-small-cell lung cancer after failure of chemotherapy

    Study Document
    Trial synopsis 1199.29 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.10
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase IIa
    Study Title

    Phase II trial of BIBF 1120 in patients with stage IIIB/IV non small cell lung cancer

    Study Document
    Trial synopsis 1199.10 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.5
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase I open label dose escalation study of continuous oral treatment with BIBF 1120 together with paclitaxel and carboplatin in patients with advanced stage non-small-cell lung cancer

    Study Document
    Trial synopsis 1199.5_CO english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.18
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open label study of continuous oral treatment with BIBF 1120 ES together with pemetrexed in previously treated patients with non-small cell lung cancer

    Study Document
    Trial synopsis 1199.18_CO english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.13
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    Multicentre, randomised, double-blind, Phase III trial to investigate the efficacyand safety of oral BIBF 1120 plus standard docetaxel therapy compared toplacebo plus standard docetaxel therapy in patients with stage IIIB/IV orrecurrent non small cell lung cancer after failure of first line chemotherapy(LUME Lung 1)

    Study Document
    Trial synopsis 1199.13 english
    Lay summary 1199.13 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.14
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    Multicentre, randomized, double-blind, Phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard pemetrexed therapy compared to placebo plus standard pemetrexed therapy in patients with stage IIIB/IV or recurrent non-small cell lung cancer after failure of first-line chemotherapy (LUME Lung 2)

    Study Document
    Trial synopsis 1199.14_PE_DS_DR english
    Trial synopsis 1199.14_FU english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.28
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    A phase I/II study of continuous, concomitant oral treatment with BIBF 1120 and pemetrexed - a phase I, open-label, dose-escalation study - a phase II, 2 arm, randomised, double-blind, placebo-controlled study in Japanese patients with stage IIIB/IV or recurrent non-small-cell lung cancer after failure of chemotherapy

    Study Document
    Trial synopsis 1199.28 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.128
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    Multicentre, randomised, double-blind, Phase III trial to investigate the efficacy and safety of oral nintedanib plus docetaxel therapy compared to placebo plus docetaxel therapy in patients with stage IIIB/IV or recurrent, adenocarcinoma subtype non-small cell lung cancer after failure of first line chemotherapy

    Study Document
    Trial statement 1199.128_DR english
    Trial synopsis 1199.128_PR english
  • Sibrotuzumab - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1152.3
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product Sibrotuzumab
    Generic Name Sibrotuzumab
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I Single Dose Escalation Study of BIBH 1 in Patients with Non-Small Cell Lung Cancer Scheduled for Resection

    Study Document
    Trial synopsis 1152.3_CO english
  • Sibrotuzumab - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1152.6
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product Sibrotuzumab
    Generic Name Sibrotuzumab
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I Single Dose Escalation Study of 131 I-Sibrotuzumab in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

    Study Document
    Trial synopsis 1152.6_CO english
  • Volasertib - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1230.5
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase II
    Study Title

    A randomized open-label Phase II trial of BI 6727 monotherapy and BI 6727 in combination with standard dose pemetrexed compared to pemetrexed monotherapy in second line non-small cell lung cancer

    Study Document
    Trial synopsis 1230.5_DR english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.90
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ib
    Study Title

    An open label Phase I safety run-in trial of oral nintedanib plus docetaxel therapy in Japanese patients with locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer after failure of platinum-based first line chemotherapy

    Study Document
    Trial synopsis 1199.90 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.48
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIIb
    Study Title

    An open label trial of afatinib in treatment-naive or chemotherapy pre-treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s)

    Study Document
    Trial synopsis 1200.48 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.208
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    An open-label, single-arm Phase IV study of afatinib in patients with stage IV or recurrent Non-Small Cell Lung Cancer who have poor performance status and whose tumors have the common epidermal growth factor receptor (EGFR) mutations, Exon 19 deletions or Exon 21(L858R) substitution mutations

    Study Document
    Trial synopsis 1200.208 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.181
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    Post marketing surveillance on long term drug use of GIOTRIF® Tablets in patients with epidermal growth factor receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC).

    Study Document
    Trial synopsis 1200.181 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.82
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    LUME-Lung 3: A Phase I/II study of continuous oral treatment with BIBF 1120 added to standard gemcitabine/cisplatin therapy in first-line NSCLC patients with squamous cell histology

    Study Document
    Trial synopsis 1199.82 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.217
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    An open-label, single-arm phase IV study to assess the efficacy and safety of afatinib as second-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring an EGFR mutation (Del19 or L858R) who have failed first-line treatment with platinum-based chemotherapy

    Study Document
    Trial synopsis 1200.217 english
  • n/a - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.227
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product n/a
    Generic Name n/a
    Lab Code n/a
    Clinical Phase IV
    Study Title

    Evaluation of the impact of nurse-led telephone follow-up on treatment compliance of patients treated for a locally advanced or metastatic nonsmall- cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutation(s). The PARTAGE study.

    Study Document
    Trial synopsis 1200.227 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.270
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    RealGiDo: Real-world data on Gi(l)otrif® dose adjustment in first-line treatment, TKI-naïve, advanced non-small cell lung cancer patients with EGFR activating mutations

    Study Document
    Trial synopsis 1200.270 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.238
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I trial to investigate the effect of nintedanib on the pharmacokinetics of a combination of ethinylestradiol and levonorgestrel in patients with nonsmall cell lung cancer

    Study Document
    Trial synopsis 1199.238 english
    Lay summary 1199.238 english
  • BI 2536 - Carcinoma, Small Cell
    Clinical Study Number 1216.11
    Study Indication Carcinoma, Small Cell
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase II
    Study Title

    An open-label Phase II trial to investigate the efficacy, safety, and pharmacokinetics of a single dose of 200 mg i.v. BI 2536 administered every 21 days in patients with sensitive relapse small cell lung cancer

    Study Document
    Trial synopsis 1216.11_CO english
  • PRADAXA ® - Cardiac Catheterization
    Clinical Study Number 1160.73
    Study Indication Cardiac Catheterization
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

    Randomized, open-label study of dabigatran etexilate, a novel, oral, direct thrombin-inhibitor in clinical development, in elective percutaneous coronary intervention. (D-Fine)

    Study Document
    Trial synopsis 1160.73 english
  • MICARDIS ® - Cardiovascular Diseases
    Clinical Study Number 502.373
    Study Indication Cardiovascular Diseases
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase III
    Study Title

    1.ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET). A large, simple, randomised, double-blind, multicentre, international trial comparing the effects of telmisartan, ramipril and their combination on outcomes in patients at high risk for cardiovascular events. 2. Telmisartan Randomized AssessmeNt Study in aCE iNtolerant subjects with cardiovascular Disease (TRANSCEND). A large, simple, randomized, double-blind, multicentre, international trial comparing the effects of telmisartan with placebo on outcomes in patients at high risk for cardiovascular events and intolerant of ACE-I

    Study Document
    Trial synopsis 502.373 Ontarget_CO english
    Trial synopsis 502.373 Transcend_CO english
  • PRADAXA ® - Cardiovascular Diseases
    Clinical Study Number 1160.121
    Study Indication Cardiovascular Diseases
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Open label, non randomized, multiple dose Phase I study to investigate the elimination, pharmacokinetics, pharmacodynamics and safety of dabigatran etexilate (Pradaxa®) under steady state conditions before, during and after haemodialysis in patients with End Stage Renal Disease (ESRD) undergoing regular haemodialysis

    Study Document
    Trial synopsis 1160.121 english
  • ACTILYSE ® - Catheter Obstruction
    Clinical Study Number 135.323
    Study Indication Catheter Obstruction
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase III
    Study Title

    A multicenter, open-label, randomised, clinical trial to compare the efficacy and safety of Actilyse® 2 mg/ 2 ml versus saline solution in restoring function of an occluded central venous access device

    Study Document
    Trial synopsis 135.323_DR english
  • BUSCOPAN ® - Colic
    Clinical Study Number 202.832
    Study Indication Colic
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase II
    Study Title

    A double-blind, placebo-controlled, randomized, parallel group study of the efficacy and safety of oral doses of 20 mg hyoscine butylbromide when used on-demand up to 7 episodes over a period of 6 weeks for the treatment of occasional episodes of self reported abdominal pain, cramping, and discomfort associated with cramping in an OTC like study population

    Study Document
    Trial synopsis 202.832_CO english
  • Afatinib + Nintedanib - Colorectal Neoplasms
    Clinical Study Number 1239.2
    Study Indication Colorectal Neoplasms
    Product Afatinib + Nintedanib
    Generic Name Afatinib + Nintedanib
    Lab Code
    Clinical Phase II
    Study Title

    A phase II trial of weekly alternating sequential administration of BIBF 1120 and BIBW 2992 in patients with advanced colorectal cancer

    Study Document
    Trial synopsis 1239.2_DR english
  • GIOTRIF ® (afatinib) - Colorectal Neoplasms
    Clinical Study Number 1200.74
    Study Indication Colorectal Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    An open label, partially randomised Phase II trial to investigate the efficacy and   safety of BIBW 2992 in patients with metastatic colorectal cancer who never   received prior anti-EGFR treatment

    Study Document
    Triall synopsis 1200.74_DR english
  • VARGATEF ® - Colorectal Neoplasms
    Clinical Study Number 1199.51
    Study Indication Colorectal Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    A phase I-II study of BIBF 1120 and Folfox compared to Bevacizumab and Folfox in first line metastatic colorectal cancer patients

    Study Document
    Trial synopsis 1199.51_DR english
  • Sibrotuzumab - Colorectal Neoplasms
    Clinical Study Number 1152.10
    Study Indication Colorectal Neoplasms
    Product Sibrotuzumab
    Generic Name Sibrotuzumab
    Lab Code
    Clinical Phase IIa
    Study Title

    A phase II uncontrolled study to evaluate the antitumour activity and safety of intravenous BIBH 1, administered in a weekly dose of 100 mg in 12 weeks, in patients with metastatic colorectal cancer.

    Study Document
    Trial synopsis 1152.10_CO english
  • VARGATEF ® - Colorectal Neoplasms
    Clinical Study Number 1199.52
    Study Indication Colorectal Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, randomised, placebo controlled Phase III study of nintedanib plus best supportive care (BSC) versus placebo plus BSC in patients with colorectal cancer refractory to standard therapies

    Study Document
    Trial synopsis 1199.52_PR english
    Lay summary 1199.52 english
  • Afatinib + Nintedanib - Colorectal Neoplasms
    Clinical Study Number 1239.6
    Study Indication Colorectal Neoplasms
    Product Afatinib + Nintedanib
    Generic Name Afatinib + Nintedanib
    Lab Code
    Clinical Phase II
    Study Title

    A multicenter, randomized, open label phase II trial evaluating the efficacy and safety of mFOLFOX7 plus weekly alternating sequential oral administration of BIBF 1120 250 mg twice daily and BIBW 2992 50 mg once daily (BB) versus mFOLFOX7 alone as first-line therapy in patients with metastatic colorectal cancer

    Study Document
    Trial statement 1239.6 english
  • VARGATEF ® - Colorectal Neoplasms
    Clinical Study Number 1199.251
    Study Indication Colorectal Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase II
    Study Title

    LUME-Colon 2: An open-label randomized phase II study to assess the efficacy and safety of nintedanib alone or in combination with capecitabine for patients with refractory metastatic colorectal cancer

    Study Document
    Trial synopsis 1199.251 english
  • ATROVENT ® - Common Cold
    Clinical Study Number 244.2503
    Study Indication Common Cold
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A Phase IV Safety Trial in Pediatric Patients (Ages 2-5) with Rhinorrhea Associated with a Common Cold or Allergy

    Study Document
    Trial synopsis 244.2503_CO english
  • MUCOVIRAL ® - Common Cold
    Clinical Study Number 1326.1
    Study Indication Common Cold
    Product MUCOVIRAL ®
    Generic Name Carrageenan
    Lab Code
    Clinical Phase IV
    Study Title

    Efficacy and safety of Iota-Carrageenan nasal spray 1.2 g/l (0.12%) (Bisolviral®) versus placebo nasal spray in the early treatment of common cold

    Study Document
    Trial synopsis 1326.1 english
  • DULCOLAX ® - Constipation
    Clinical Study Number 122.56
    Study Indication Constipation
    Product DULCOLAX ®
    Generic Name Bisacodyl
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of 4 weeks with bisacodyl (Dulcolax®) tablets 10mg administered orally, once daily, in patients with functional constipation.

    Study Document
    Trial synopsis 122.56_DS_DR english
  • DULCOLAX ® - Constipation
    Clinical Study Number 122.52
    Study Indication Constipation
    Product DULCOLAX ®
    Generic Name Bisacodyl
    Lab Code
    Clinical Phase IIIb
    Study Title

    Comparative efficacy and tolerability of bisacodyl sugar coated tablets, simeticone chewing tablets and the combination of both in the treatment of constipation and bloatedness: an open, randomised, parallel group trial

    Study Document
    Trial synopsis 122.52_CO english
  • LAXOBERAL ® - Constipation
    Clinical Study Number 1062.7
    Study Indication Constipation
    Product LAXOBERAL ®
    Generic Name Sodium picosulfate
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of 4 weeks treatment with sodium picosulfate [Dulcolax®, Laxoberal®] drops 10 mg administered orally, once daily, in patients with functional constipation

    Study Document
    Trial synopsis 1062.7_DR english
  • AGGRENOX ® - Coronary Artery Disease
    Clinical Study Number 9.169
    Study Indication Coronary Artery Disease
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, crossover study comparing the biochemical and platelet effects of modified-release dipyridamole/aspirin (200mg/25 mg bd; Asasantin Retard®) with aspirin (75 mg qd) in coronary artery disease patients with aspirin resistance manifesting as persistent thromboxane formation.

    Study Document
    Trial synopsis 9.169_CO english
  • BI 695500 - Coronary Artery Disease , Lymphoma, Non-Hodgkin
    Clinical Study Number 1301.2
    Study Indication Coronary Artery Disease ; Lymphoma, Non-Hodgkin
    Product BI 695500
    Generic Name BI 695500
    Lab Code BI 695500
    Clinical Phase III
    Study Title

    A randomized, double-blind, multi-center, multi-national Phase III trial to compare efficacy and safety of BI 695500 plus chemotherapy versus rituximab plus chemotherapy in patients with untreated follicular non- Hodgkin’s lymphoma

    Study Document
    Trial statement 1301.2 english
  • PRADAXA ® - Coronary Disease
    Clinical Study Number 1160.67
    Study Indication Coronary Disease
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

    RandomizEd Dabigatran Etexilate dose finding study in patients with acute coronary syndromes post index Event with additional risk factors for cardiovascular complications also receiving aspirin and clopidogrel: Multi-centre, prospective, placebo-controlled, group dose escalation trial (RE-DEEM STUDY)

    Study Document
    Trial synopsis 1160.67_DR english
  • Doramapimod - Crohn Disease
    Clinical Study Number 1175.12
    Study Indication Crohn Disease
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, double-blind, placebo-controlled, four parallel groups, dose finding study of BIRB 796 BS (10, 20 and 30 mg) administered twice a day orally over 8 weeks in patients with moderate to servere Crohn´s disease followed by a 18 weeks treatment extension in patients with Clinical Remission or Clinical Response after 8 weeks treatment with the respective dose of BIRB 796 BS

    Study Document
    Trial synopsis 1175.12 english
    Trial synopsis 1175.12_ext english
  • Risankizumab - Crohn Disease
    Clinical Study Number 1311.6
    Study Indication Crohn Disease
    Product Risankizumab
    Generic Name Risankizumab
    Lab Code BI 655066
    Clinical Phase II
    Study Title

    A Phase 2, Multicenter, Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease Who Are Naïve to or Were Previously Treated With Anti-TNF Therapy

    Study Document
    Trial synopsis 1311.6 English
  • Amelubant - Cystic Fibrosis
    Clinical Study Number 543.36
    Study Indication Cystic Fibrosis
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase Ib
    Study Title

    A randomized, double-blind within dose, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of increasing single oral doses of BIIL 284 BS in adult and pediatric cystic fibrosis patients

    Study Document
    Trial synopsis 543.36_CO english
  • Amelubant - Cystic Fibrosis
    Clinical Study Number 543.37
    Study Indication Cystic Fibrosis
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase Ib
    Study Title

    A randomized, double-blind within dose, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of repeated oral doses (15-day dosing) of BIIL 284 BS in adult (150 mg) and pediatric (75 mg) cystic fibrosis patients 

    Study Document
    Trial synopsis 543.37 english
  • SPIRIVA ® - Cystic Fibrosis
    Clinical Study Number 205.338
    Study Indication Cystic Fibrosis
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase I
    Study Title

    A randomized, double-blind within dose, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of increasing single and multiple doses (28-day dosing) of tiotropium bromide administered once daily via the Respimat® device in cystic fibrosis patients

    Study Document
    Trial synopsis 205.338_CO english
  • SPIRIVA ® - Cystic Fibrosis
    Clinical Study Number 205.339
    Study Indication Cystic Fibrosis
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat® device for 12 weeks in patients with cystic fibrosis

    Study Document
    Trial synopsis 205.339_DS_CO english
  • SPIRIVA ® - Cystic Fibrosis
    Clinical Study Number 205.438
    Study Indication Cystic Fibrosis
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis

    Study Document
    Trial synopsis 205.438_DS_CO english
  • GLADEM ® - Depressive Disorder
    Clinical Study Number 533.2
    Study Indication Depressive Disorder
    Product GLADEM ®
    Generic Name Sertraline
    Lab Code
    Clinical Phase IV
    Study Title

    Observational study via internet to assess a 6-months treatment with GLADEM

    Study Document
    Trial synopsis 533.2 english
  • YENTREVE ® - Depressive Disorder, Major
    Clinical Study Number 1208.24
    Study Indication Depressive Disorder, Major
    Product YENTREVE ®
    Generic Name Duloxetine
    Lab Code
    Clinical Phase IV
    Study Title

    An eight-week, randomized, double-blind, two parallel groups, study to assess clinical response of duloxetine 60 mg and 120 mg per day in patients hospitalized for severe depression.

    Study Document
    Trial synopsis 1208.24_DR english
  • YENTREVE ® - Depressive Disorder, Major
    Clinical Study Number 1208.10
    Study Indication Depressive Disorder, Major
    Product YENTREVE ®
    Generic Name Duloxetine
    Lab Code
    Clinical Phase IIIb
    Study Title

    A ten-week, randomized, double-blind study evaluating the efficacy of duloxetine 60 mg once daily versus placebo in outpatients with major depressive disorder and pain (EU-Pain enriched study)

    Study Document
    Trial synopsis 1208.10 english
  • ALESION ® - Dermatitis, Atopic
    Clinical Study Number 262.259
    Study Indication Dermatitis, Atopic
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase III
    Study Title

    Phase III Double-Blind Comparative Study of WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

    Study Document
    Trial synopsis 262.259 english
  • ALESION ® - Dermatitis, Atopic
    Clinical Study Number 262.260
    Study Indication Dermatitis, Atopic
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase III
    Study Title

    Phase III Open-labeled Study of WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

    Study Document
    Trial synopsis 262.260 english
  • JARDIANCE ® - Diabetes Mellitus, Type 1
    Clinical Study Number 1245.78
    Study Indication Diabetes Mellitus, Type 1
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIa
    Study Title

    A 28-day randomised, placebo-controlled, double-blind parallel group phase IIa trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of once daily oral doses of 2.5 mg, 10 mg, and 25 mg empagliflozin as adjunctive to insulin in patients with type 1 diabetes mellitus (EASE-1)

    Study Document
    Trial synopsis 1245.78 english
  • JARDIANCE ® - Diabetes Mellitus, Type 1
    Clinical Study Number 1245.46
    Study Indication Diabetes Mellitus, Type 1
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase II
    Study Title

    An open-label 8-week adjunctive-to-insulin and renal mechanistic pilot trial of BI 10773 in type 1 diabetes mellitus (the ATIRMA trial)

    Study Document
    Trial synopsis 1245.46_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 1
    Clinical Study Number 1245.113
    Study Indication Diabetes Mellitus, Type 1
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase II
    Study Title

    A phase II, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily, oral doses of empagliflozin as adjunctive to insulin therapy for 28 days in Japanese patients with type 1 diabetes mellitus

    Study Document
    Trial synopsis 1245.113 english
  • JARDIANCE ® - Diabetes Mellitus, Type 1
    Clinical Study Number 1245.69
    Study Indication Diabetes Mellitus, Type 1
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive to inSulin thErapy over 52 weeks in patients with Type 1 Diabetes Mellitus (EASE-2)

    Study Document
    Trial synopsis 1245.69 english
  • JARDIANCE ® - Diabetes Mellitus, Type 1
    Clinical Study Number 1245.72
    Study Indication Diabetes Mellitus, Type 1
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive to inSulin thErapy over 26 weeks in patients with Type 1 Diabetes Mellitus (EASE-3)

    Study Document
    Trial synopsis 1245.72 english
  • BI 135585 - Diabetes Mellitus, Type 2
    Clinical Study Number 1283.2
    Study Indication Diabetes Mellitus, Type 2
    Product BI 135585
    Generic Name BI 135585
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple-rising oral doses (5 to 100 mg q.d. for 14 days) of BI 135585 XX in patients with type 2 diabetes mellitus (randomised, double-blind, placebo-controlled within dose groups)

    Study Document
    Trial synopsis 1283.2 english
  • BI 44847 - Diabetes Mellitus, Type 2
    Clinical Study Number 1224.3
    Study Indication Diabetes Mellitus, Type 2
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of four multiple rising oral doses (50-800 mg b.i.d. or q.d. for 8 days) of BI 44847 as tablet in female and male patients with type 2 diabetes

    Study Document
    Trial synopsis 1224.3_CO english
  • BI 44847 - Diabetes Mellitus, Type 2
    Clinical Study Number 1224.4
    Study Indication Diabetes Mellitus, Type 2
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of 4 weeks treatment with three selected oral doses of BI 44847 as tablet in female and male patients with type 2 diabetes

    Study Document
    Trial synopsis 1224.4 english
  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.1
    Study Indication Diabetes Mellitus, Type 2
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase IIIa
    Study Title

    A phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of once daily oral administration of BI 10773 25 mg/linagliptin 5 mg and BI 10773 10 mg/linagliptin 5 mg Fixed Dose Combination tablets compared with the individual components (BI 10773 25 mg, BI 10773 10 mg, and linagliptin 5 mg) for 52 weeks in treatment naive and metformin treated patients with type 2 diabetes mellitus with insufficient glycaemic control

    Study Document
    Trial synopsis 1275.1_DS_DR english
  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.9
    Study Indication Diabetes Mellitus, Type 2
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind, parallel group, 24 week study to evaluate efficacy and safety of once daily empagliflozin 10 mg and 25 mg compared to placebo, all administered as oral fixed dose combinations with linagliptin 5 mg, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks treatment with linagliptin 5 mg once daily on metformin background therapy.

    Study Document
    Trial synopsis 1275.9_DR english
  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.10
    Study Indication Diabetes Mellitus, Type 2
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase IIIb
    Study Title

    A phase III, randomized, double-blind, parallel group study to evaluate the efficacy and safety of linagliptin 5 mg compared to placebo, administered as oral fixed dose combination with empagliflozin 10 mg or 25 mg for 24 weeks, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg or 25 mg on metformin background therapy

    Study Document
    Trial synopsis 1275.10_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.2
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of 4 multiple rising oral doses (2.5 mg to 100 mg) of BI 10773 tablets in male and female type 2 diabetic patients

    Study Document
    Trial synopsis 1245.2_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.4
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of 4 weeks treatment with three oral doses of BI 10773 as tablets in female and male patients with type 2 diabetes

    Study Document
    Trial synopsis 1245.4_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.9
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIb
    Study Title

    A Phase IIb, randomized, parallel group safety, efficacy, and pharmacokinetics study of BI 10773 (5 mg, 10 mg and 25 mg) administered orally once daily over 12 weeks compared double blind to placebo, as monotherapy, with an additional open-label metformin arm in type 2 diabetic patients with insufficient glycemic control

    Study Document
    Trial synopsis 1245.9_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.10
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIb
    Study Title

    A Phase II, randomized, parallel group safety, efficacy, and pharmacokinetics study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) administered orally once daily over 12 weeks compared double blind to placebo with an additional open-label sitagliptin arm in type 2 diabetic patients with insufficient glycemic control despite metformin therapy

    Study Document
    Trial synopsis 1245.10_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.12
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, pharmacodynamics, safety and tolerability of a single 50 mg dose of BI 10773 in patients with different degrees of renal impairment in comparison to subjects with type 2 diabetes and normal renal function in a monocentric, open-label, parallel-group, phase 1 trial

    Study Document
    Trial synopsis 1245.12 english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.15
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II, randomised, double-blind, placebo-controlled, multiple dose study to evaluate pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 (1 mg, 5 mg, 10 mg, and 25 mg) for 28 days in Japanese patients with type 2 diabetes mellitus

    Study Document
    Trial synopsis 1245.15_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.19
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled parallel group efficacy and safety trial of BI 10773 (10 and 25 mg administered orally once daily) over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycaemic control despite a background therapy of pioglitazone alone or in combination with metformin

    Study Document
    Trial synopsis 1245.19_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.20
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, double-blind, placebo-controlled, parallel group,efficacy and safety study of BI 10773 and sitagliptin administered orally over 24 weeks, in drug naive patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet and exercise

    Study Document
    Trial synopsis 1245.20_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.23
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, double-blind, placebo-controlled, parallel group,efficacy and safety study of BI 10773 (10 mg, 25 mg) administered orally, once daily over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulphonylurea

    Study Document
    Trial synopsis 1245.23_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.24
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIb
    Study Title

    A 78 week open label extension to trials assessing the safety and efficacy of BI 10773 as monotherapy or in combination with metformin in type 2 diabetic patients

    Study Document
    Trial synopsis 1245.24_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.31
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III double-blind, extension, placebo-controlled parallel group safety and efficacy trial of BI 10773 (10 and 25 mg once daily) and sitagliptin (100 mg once daily) given for minimum 76 weeks (including 24 weeks of preceding trial) as monotherapy or with different background therapies in patients with type 2 diabetes mellitus previously completing trial 1245.19, 1245.20 or 1245.23

    Study Document
    Trial synopsis 1245.31_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.33
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIb
    Study Title

    A phase IIb, randomized, double-blind, placebo-controlled, parallel group, safetyand efficacy study of BI 10773 (10 mg and 25 mg) administered orally, once daily over 78 weeks in type 2 diabetic patients receiving treatment with basal insulin (glargine, detemir, or NPH insulin only) with or without concomitant metformin and/or sulfonylurea therapy and insufficient glycemic control

    Study Document
    Trial synopsis 1245.33_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.36
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg and 25 mg administered once daily) as add on to pre-existing antidiabetic therapy over 52 weeks in patients with type 2 diabetes mellitus and renal impairment and insufficient glycaemic control.

    Study Document
    Trial synopsis 1245.36_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.38
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIb
    Study Title

    A double-blind, randomised, parallel group efficacy and safety study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) compared to placebo when administered orally once daily over 12 weeks, as monotherapy, in patients with type 2 diabetes and insufficient glycaemic control despite diet and exercise, followed by a 40 week randomised extension study to assess long term safety of BI 10773 (10 mg and 25 mg)

    Study Document
    Trial synopsis 1245.38_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.42
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of pharmacodynamic and pharmacokinetic interactions between25 mg BI 10773 and 25 mg hydrochlorothiazide or 5 mg torasemide under steady state conditions in patients with type 2 diabetes mellitus in an open-label, randomised, cross-over trial

    Study Document
    Trial synopsis 1245.42 english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.44
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and pharmacodynamics of BI 10773 after single and multiple oral doses of 10 mg and 25 mg BI 10773 in Chinese male and female type 2 diabetic patients

    Study Document
    Trial synopsis 1245.44_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.48
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg, 25 mg) administered orally, once daily over 12 weeks in hypertensive patients with type 2 diabetes mellitus

    Study Document
    Trial synopsis 1245.48_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.49
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomized, double-blind, placebo-controlled, parallel group safety and efficacy study of BI 10773 (10 mg and 25 mg administered orally once daily) during 52 weeks in patients with type 2 diabetes mellitus and insufficient glycemic control on MDI insulin regimen alone or with metformin

    Study Document
    Trial synopsis 1245.49_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.52
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A 52-week, randomised, multi-centre, parallel group study to investigate the safety and efficacy of BI 10773 (10 mg or 25 mg administered orally once daily) as add-on therapy to an oral antidiabetic drug (sulfonylurea, biguanide, thiazolidinedione, alpha glucosidase inhibitor, DPP-IV inhibitor, or glinide) in patients with type 2 diabetes mellitus with insufficient glycaemic control

    Study Document
    Trial synopsis 1245.52_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.53
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I, open-label, parallel-group study to investigate pharmacokinetics, pharmacodynamics and safety of a single 25 mg dose of Empagliflozin in Japanese type 2 diabetes patients with different degrees of renal impairment in comparison to type 2 diabetes patients with normal renal function

    Study Document
    Trial synopsis 1245.53_DS_CO english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.39
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase II
    Study Title

    An open-label, phase II study to determine acute (after the first dose administration) and chronic (after 28 days of treatment) effects of the sodium-glucose co-transporter-2 (SGLT-2) inhibitor empagliflozin (BI 10773) (25 mg once daily) on pre and postprandial glucose homeostasis in patients with IGT and, type 2 diabetes mellitus and healthy subjects

    Study Document
    Trial synopsis 1245.39_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.35
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, placebo-controlled, parallel group, 4-week study to evaluate the efficacy of empagliflozin (10 mg and 25 mg administered orally once daily) in postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control

    Study Document
    Trial synopsis 1245.35_DR english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.28
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 compared to glimepiride administered orally during 104 weeks with a 104 week extension period in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment

    Study Document
    Trial synopsis 1245.28_main report english
    Trial synopsis 1245.28_final report english
    Lay summary 1245.28 main report english
    Lay summary 1245.28 final report english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.25
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase IIIa
    Study Title

    A Phase III, multicentre, international, randomised, parallel group, double blind cardiovascular safety study of BI 10773 (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular risk

    Study Document
    Trial synopsis 1245.25_DR english
    Lay summary 1245.25 english
  • JARDIANCE ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1245.87
    Study Indication Diabetes Mellitus, Type 2
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomised, multicentre, single-dose, parallel group trial to evaluate pharmacokinetics and pharmacodynamics of empagliflozin in children and adolescents from 10 to less than 18 years of age with type 2 diabetes mellitus

    Study Document
    Trial synopsis 1245.87_DR english
  • JENTADUETO ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1288.18
    Study Indication Diabetes Mellitus, Type 2
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase IIIb
    Study Title

    A phase III randomised, double-blind, double-dummy, parallel group study to compare the efficacy and safety of twice daily administration of the fix dose combination of Linagliptin 2.5 mg + metformin 500 mg, or of Linagliptin 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg, twice daily), and Linagliptin (5.0 mg, once daily) over 24 weeks in treatment naive type 2 diabetic patients with insufficient glycaemic control

    Study Document
    Trial synopsis 1288.18_DR english
  • JENTADUETO ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1288.19
    Study Indication Diabetes Mellitus, Type 2
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    A Single-Dose, Comparative Bioavailability Study of Linagliptin/Metformin Hydrochloride 2.5 mg/500 mg Combination Tablets versus Linagliptin 2.5 mg Tablets Administered with Glucophage® 500 mg Tablets under Fasting Conditions

    Study Document
    Trial synopsis 1288.19 english
  • Linagliptin + Pioglitazone - Diabetes Mellitus, Type 2
    Clinical Study Number 1264.3
    Study Indication Diabetes Mellitus, Type 2
    Product Linagliptin + Pioglitazone
    Generic Name Linagliptin + Pioglitazone
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind parallel group study to compare the efficacy and safety of initial combination therapy with linagliptin 5 mg + pioglitazone 15 mg, 30 mg, or 45 mg, vs. monotherapy with pioglitazone (15 mg, 30 mg, or 45 mg) or linagliptin 5 mg once daily for 30 weeks, followed by a blinded trial period on linagliptin 5 mg + pioglitazone 30 or 45 mg versus pioglitazone monotherapy 30 or 45 mg or linagliptin 5 mg for up to 54 weeks in type 2 diabetic patients with insufficient glycaemic control on diet and exercise

    Study Document
    Trial synopsis 1264.3_DR english
  • MICARDIS ® - Diabetes Mellitus, Type 2
    Clinical Study Number 502.398
    Study Indication Diabetes Mellitus, Type 2
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase IV
    Study Title

    A prospective, randomized, double-blind, double-dummy, forced titration, parallel group comparison, multicenter trial to compare the effects of either telmisartan (40-80 mg p.o. once daily) or ramipril (5-10 mg p.o. once daily) on renal endothelial dysfunction in hypertensive patients with type 2 diabetes and normo- or microalbuminuria over a treatment period of 9 weeks

    Study Document
    Trial synopsis 502.398_CO english
  • SYNJARDY ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1276.1
    Study Indication Diabetes Mellitus, Type 2
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase III
    Study Title

    A 24-week phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of twice daily oral administration of empagliflozin + metformin compared with the individual components of empagliflozin or metformin in drug naive patients with type 2 diabetes mellitus

    Study Document
    Trial synopsis 1276.1_DR english
  • SYNJARDY ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1276.10
    Study Indication Diabetes Mellitus, Type 2
    Product SYNJARDY ®
    Generic Name Empagliflozin + Metformin
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double blind, placebo controlled, parallel group efficacy and safety study of oral administration of empagliflozin twice daily versus once daily in two different daily doses over 16 weeks as add-on therapy to a twice daily dosing regimen of metformin in patients with type 2 diabetes mellitus and insufficient glycaemic control

    Study Document
    Trial synopsis 1276.10_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.43
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind, placebo-controlled, parallel group, safety and efficacy study of BI 1356 (5 mg), compared to placebo as add on to pre-existing antidiabetic therapy (insulin or any combination with insulin; sulphonylurea or glinides as monotherapy; pioglitazone or any other antidiabetics, excluding only DPP-4 inhibitors other than BI 1356) over 52 weeks in type 2 diabetic patients with severe chronic renal impairment

    Study Document
    Trial synopsis 1218.43_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.15
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo controlled, parallel group 24 week study to assess the efficacy and safety of linagliptin (5 mg) in combination with 30 mg pioglitazone (both administered orally once daily), compared to 30 mg pioglitazone plus placebo in drug-naive or previously treated type 2 diabetic patients with insufficient glycaemic control

    Study Document
    Trial synopsis 1218.15_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.17
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of linagliptin (5 mg administered orally once daily) over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy

    Study Document
    Trial synopsis 1218.17_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.18
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of linagliptin (5 mg) administered orally once daily over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite a therapy of metformin in combination with a sulphonylurea

    Study Document
    Trial synopsis 1218.18_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.20
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, active-controlled parallel group efficacy and safety study of linagliptin (5 mg, administered orally once daily) compared to glimepiride (1 to 4 mg once daily) over two years, in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy

    Study Document
    Trial synopsis 1218.20_DS_CO english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.40
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase IIIb
    Study Title

    A 78 week open-label extension to trials assessing the safety and efficacy of linagliptin (5 mg) as monotherapy or in combination with other antidiabetic medications in type 2 diabetic patients

    Study Document
    Trial synopsis 1218.40_DR english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.46
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg, or of linagliptin 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg, twice daily) and linagliptin (5 mg, once daily) over 24 weeks in drug naive or previously treated (4 weeks washout and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control

    Study Document
    Trial synopsis 1218.46 english
  • TRADJENTA ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1218.50
    Study Indication Diabetes Mellitus, Type 2
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, parallel group efficacy and safety study of linagliptin (BI 1356) (5 mg), administered orally once daily for 18 weeks followed by a 34 week double-blind extension period (placebo patientsswitched to glimepiride) in Type 2 diabetic patients with insufficient glycaemic control for whom metformin therapy is inappropriate (intolerability or contraindica