Value through Innovation27 July 2016

Clinical Study Results

  • 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 Lay summary 1320.22 english
  • BI 409306 - Schizophrenia
    Clinical Study Number 1289.6
    Study Indication Schizophrenia
    Product BI 409306
    Generic Name BI 409306
    Lab Code BI 409306
    Clinical Phase II
    Study Title

    A phase II randomised, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of four orally administrated doses of BI 409306 during a 12-week treatment period in patients with schizophrenia on stable antipsychotic treatment

    Study Document Lay summary 1289.6 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 Lay summary 1289.7 english
  • 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 Lay summary 1289.5 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 Lay summary 1297.2 english
  • GIOTRIF ® (afatinib) - Head and Neck Neoplasms
    Clinical Study Number 1200.43
    Study Indication Head and Neck Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Head & Neck 1: A randomised, open-label, phase III study to evaluate the efficacy and safety of oral afatinib (BIBW 2992) versus intravenous methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who have progressed after platinum-based therapy

    Study Document Lay summary 1200.43 english Lay summary 1200.43 czech Lay summary 1200.43 danish Lay summary 1200.43 dutch Lay summary 1200.43 french Lay summary 1200.43 german Lay summary 1200.43 greek Lay summary 1200.43 italian Lay summary 1200.43 spanish Lay summary 1200.43 swedish
  • 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 Lay summary 1200.32 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
  • 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
  • GIOTRIF ® (afatinib) - Glioma
    Clinical Study Number 1200.38
    Study Indication Glioma
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I, open label trial to explore safety of combining BIBW 2992 and radiotherapy with or without temozolomide in newly diagnosed GBM

    Study Document Lay summary 1200.38 english
  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.19
    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, 52 week study to evaluate efficacy and safety of once daily empagliflozin and linagliptin fixed dose combination compared with linagliptin plus placebo in Japanese type 2 diabetes mellitus patients with insufficient glycaemic control after 16 weeks treatment with once daily linagliptin 5 mg.

    Study Document Lay summary 1275.19 english
  • GLYXAMBI ® - Diabetes Mellitus, Type 2
    Clinical Study Number 1275.13
    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 linagliptin 5 mg fixed dose combination compared with empagliflozin 10 mg plus placebo and a 52- week study to evaluate efficacy and safety of once daily empagliflozin 25 mg and linagliptin 5 mg fixed dose combination compared with empagliflozin 25 mg plus placebo (including a 28-week extension period to investigate the longterm safety) in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16-week treatment with empagliflozin (10 mg or 25 mg) alone once daily

    Study Document Lay summary 1275.13 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 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 Lay summary 1245.25 english
  • OFEV ® - Idiopathic Pulmonary Fibrosis
    Clinical Study Number 1199.32
    Study Indication Idiopathic Pulmonary Fibrosis
    Product OFEV ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline, in patients with Idiopathic Pulmonary Fibrosis (IPF)

    Study Document Lay summary 1199.32 english Lay summary 1199.32 czech Lay summary 1199.32 dutch Lay summary 1199.32 finnish Lay summary 1199.32 french Lay summary 1199.32 german Lay summary 1199.32 greek Lay summary 1199.32 italian Lay summary 1199.32 portuguese Lay summary 1199.32 spanish Lay summary 1199.32 swedish
  • OFEV ® - Idiopathic Pulmonary Fibrosis
    Clinical Study Number 1199.34
    Study Indication Idiopathic Pulmonary Fibrosis
    Product OFEV ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline, in patients with Idiopathic Pulmonary Fibrosis (IPF)

    Study Document Lay summary 1199.34 english Lay summary 1199.34 czech Lay summary 1199.34 dutch Lay summary 1199.34 finnish Lay summary 1199.34 french Lay summary 1199.34 german Lay summary 1199.34 greek Lay summary 1199.34 italian Lay summary 1199.34 portuguese Lay summary 1199.34 spanish Lay summary 1199.34 swedish
  • OFEV ® - Idiopathic Pulmonary Fibrosis
    Clinical Study Number 1199.187
    Study Indication Idiopathic Pulmonary Fibrosis
    Product OFEV ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase IIIb
    Study Title

    A six month double blind randomized placebo controlled trial followed by each arm being converted to oral nintedanib 150 mg twice daily comparing the effect on high resolution computerized tomography quantitative lung fibrosis score, lung function, six minute walk test distance and St. George’s Respiratory Questionnaire after six months of treatment in patients with Idiopathic Pulmonary Fibrosis with continued evaluations over a period of up to eighteen months

    Study Document Lay summary 1199.187 english
  • OFEV ® - Idiopathic Pulmonary Fibrosis
    Clinical Study Number 1199.33
    Study Indication Idiopathic Pulmonary Fibrosis
    Product OFEV ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    An open-label extension trial of the long-term safety of oral BIBF 1120 in patients with idiopathic pulmonary fibrosis (IPF)

    Study Document Lay summary 1199.33 english Lay summary 1199.33 czech Lay summary 1199.33 dutch Lay summary 1199.33 finnish Lay summary 1199.33 french Lay summary 1199.33 german Lay summary 1199.33 greek Lay summary 1199.33 italian Lay summary 1199.33 portuguese Lay summary 1199.33 spanish Lay summary 1199.33 swedish
  • 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 Lay summary 1160.204 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 Lay summary 1160.186 english
  • PRAXBIND ® - Hemorrhage
    Clinical Study Number 1321.3
    Study Indication Hemorrhage
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0 g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. RE-VERSE-AD (A study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) trial

    Study Document Lay summary 1321.3 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.16
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    An exploratory, 12 week, randomised, partially double-blinded, placebo-controlled parallel group trial to explore the effects of once daily treatments of orally inhaled tiotropium + olodaterol fixed dose combination or tiotropium (both delivered by Respimat® inhaler), supervised exercise training and behavior modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Lay summary 1237.16 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.28
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, double-blind, cross-over study to evaluate the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (5/5 μg) compared with tiotropium (5 μg), both delivered by the Respimat® Inhaler, on breathlessness during the three minute Constant Speed Shuttle Test (3min CSST) in patients with Chronic Obstructive Pulmonary Disease (COPD) [OTIVATOTM]

    Study Document Lay summary 1237.28 english Lay summary 1237.28 dutch Lay summary 1237.28 french Lay summary 1237.28 german
  • VARGATEF ® - Ovarian Neoplasms
    Clinical Study Number 1199.15
    Study Indication Ovarian Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase IIIa
    Study Title

    Multicenter, randomised, double-blind Phase III trial to investigate the efficacy and safety of BIBF 1120 in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in patients with advanced ovarian cancer

    Study Document Lay summary 1199.15 english
  • VARGATEF ® - Ovarian Neoplasms
    Clinical Study Number 1199.119
    Study Indication Ovarian Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I dose escalation trial to determine the maximum tolerated dose of BIBF 1120 in combination with carboplatin and pegylated liposomal doxorubicin (PLD) in patients with a first, second or third platinum sensitive relapse of advanced epithelial ovarian cancer, fallopian tube or primary peritoneal cancer

    Study Document Lay summary 1199.119 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 Lay summary 1199.13 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 Lay summary 1199.52 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 Lay summary 1199.238 english
  • Volasertib - Leukemia, Myeloid, Acute
    Clinical Study Number 1230.30
    Study Indication Leukemia, Myeloid, Acute
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label, Phase I, dose escalation trial to investigate the maximum tolerated dose, safety, pharmacokinetics, and efficacy of volasertib in combination with decitabine in patients >= 65 years with acute myeloid leukemia

    Study Document Lay summary 1230.30 english
  • Volasertib - Neoplasms , Leukemia
    Clinical Study Number 1230.27
    Study Indication Neoplasms ; Leukemia
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    Open, non-controlled, dose-escalating Phase I trial to evaluate the pharmacokinetics, pharmacodynamics, tolerability, and toxicity of volasertib in paediatric patients from 2 years to less than 18 years of age with acute leukaemia or advanced solid tumour, for whom no effective treatment is known

    Study Document Lay summary 1230.27 english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.