Value through Innovation27 July 2016

What is a lay summary?

Clinical Study Results

  • ACTILYSE ® - Stroke
    Clinical Study Number 135.312
    Study Indication Stroke
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IIIb
    Study Title

    ECASS III – European Cooperative Acute Stroke Study III: A placebo controlled trial of alteplase in acute ischemic hemispheric stroke where thrombolysis is initiated between 3 and 4 hours 30 minutes after stroke onset.

    Study Document
    Trial synopsis 135.312_CO english
  • ACTILYSE ® - Stroke
    Clinical Study Number 135.313
    Study Indication Stroke
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IV
    Study Title

    Safe implements of Thrombolysis in Stroke -MOnitoring STudy (SITS-MOST)

    Study Document
    Trial synopsis 135.313_CO english
  • ACTILYSE ® - Stroke
    Clinical Study Number 135.315
    Study Indication Stroke
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IV
    Study Title

    Actilyse PMS study final report

    Study Document
    Trial synopsis 135.315_CO english
  • ACTILYSE ® - Myocardial Infarction
    Clinical Study Number 135.301
    Study Indication Myocardial Infarction
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IV
    Study Title

    A multicentre, feasibility study of pre-hospital treatment of acute myocardial infarction based on diagnosis by interpretation of remotely acquired ECG and thrombolysis with accelerated alteplase (Actilyse®). Pre-Hospital Alteplase Remote Advice Of Hospital (PHARAOH)

    Study Document
    Trial synopsis 135.301 english
  • ACTILYSE ® - Stroke
    Clinical Study Number 135.317
    Study Indication Stroke
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IV
    Study Title

    SITS-NEW Safe Implementation of Thrombolysis in Stroke in the Non EUWorld: An International observational study of the Safety and Efficacy of Thrombolysis in stroke

    Study Document
    Trial synopsis 135.317 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
  • ACTILYSE ® - Stroke
    Clinical Study Number 135.331
    Study Indication Stroke
    Product ACTILYSE ®
    Generic Name Alteplase
    Lab Code
    Clinical Phase IIIb
    Study Title

    An open label, multicentre, single-arm trial to assess safety and efficacy of alteplase (rt-PA) in Chinese patients with acute ischemic hemispheric stroke where thrombolysis is initiated between 3 and 4.5 hours after stroke onset

    Study Document
    Trial synopsis 135.331 english
  • Afatinib + Nintedanib - Neoplasms
    Clinical Study Number 1239.1
    Study Indication Neoplasms
    Product Afatinib + Nintedanib
    Generic Name Afatinib + Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    A combination Phase I open-label dose escalation study of concomitant administration of BIBW 2992 with BIBF 1120 in patients with advanced solid tumors

    Study Document
    Trial synopsis 1239.1_DR 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
  • Afatinib + Nintedanib - Prostatic Neoplasms
    Clinical Study Number 1239.3
    Study Indication Prostatic Neoplasms
    Product Afatinib + Nintedanib
    Generic Name Afatinib + Nintedanib
    Lab Code
    Clinical Phase II
    Study Title

    A multi-centre 3-arm randomised phase II trial of BIBF 1120 versus BIBW 2992 versus sequential administration of BIBF 1120 and BIBW 2992 in patients with hormone-resistant prostate cancer

    Study Document
    Trial synopsis 1239.3_DS_DR english
  • Afatinib + Nintedanib - Neoplasms
    Clinical Study Number 1239.14
    Study Indication Neoplasms
    Product Afatinib + Nintedanib
    Generic Name Afatinib + Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I Dose escalation study of concomitant BIBF 1120 and BIBW 2992 in patients with advanced solid tumours.

    Study Document
    Trial synopsis 1239.14_PE english
    Trial synopsis 1239.14 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
  • AGGRENOX ® - Stroke
    Clinical Study Number 9.182
    Study Indication Stroke
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase IV
    Study Title

    Prospective, randomised, national, multi-centre, open-label, blinded endpoint study to compare Aggrenox® b.i.d. (200 mg dipyridamole MR + 25 mg acetylsalicylic acid) when started within 24 hours of stroke onset on an acute stroke unit, and Aggrenox® b.i.d. when started after a 7-day therapy with ASA 100 mg once daily outside of an acute stroke unit, in symptomatic ischaemic stroke patients over a three months treatment period (EARLY) - An exploratory study

    Study Document
    Trial synopsis 9.182_DS_DR english
  • AGGRENOX ® - Stroke
    Clinical Study Number 9.178
    Study Indication Stroke
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase III
    Study Title

    Japanese Aggrenox Stroke Prevention vs. Aspirin Programme (JASAP): Phase III study to evaluate the preventive effect of recurrent cerebral infarction and safety of Aggrenox (a combination drug containing sustained-release dipyridamole 200 mg and acetylsalicylic acid 25 mg) twice daily compared with acetylsalicylic acid 81 mg once daily

    Study Document
    Trial Synopsis 9.178_CO 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
  • AGGRENOX ® - Stroke
    Clinical Study Number 9.155
    Study Indication Stroke
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase III
    Study Title

    Tolerability of a Four Weeks Treatment with Aggrenox® Modified Release Capsules b.i.d, Compared to Reduced Dose During the First Two Weeks of Treatment in a Double-Blind, Randomized Controlled Parallel Group Comparison Trial among Taiwanese Patients with Previous TIAs or Ischemic Stroke

    Study Document
    Trial synopsis 9.155 english
  • AGGRENOX ® - Stroke
    Clinical Study Number 9.159
    Study Indication Stroke
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase III/IV
    Study Title

    PRoFESS – Prevention Regimen For Effectively avoiding Second Strokes: A double-blind, active and placebo controlled study of Aggrenox® vs. clopidogrel, with and without Micardis®

    Study Document
    Trial synopsis 9.159_DS_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.197
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Drug-Drug Interaction Study of the Effect of Omeprazole 80 mg q.d. at Steady State on the Pharmacokinetics and Pharmacodynamics of Aggrenox ® Every 12 Hours at Steady State in Healthy Male and Female Volunteers (an Open-Label, Randomized, Crossover Study)

    Study Document
    Trial synopsis 9.197_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.127
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and safety of Asasantin extended release (RAD-SP) 200/25 mg capsules b.i.d. in randomised, double-blind, placebo­ controlled study in Japanese healthy male volunteers

    Study Document
    Trial synopsis 9.127_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.130
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, two-period, cross over trial to compare the effects of acetylsalicylic acid (75 mg/day) with the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) (bd) on serum thromboxane B2 formation and platelet aggregation in healthy volunteers

    Study Document
    Trial synopsis 9.130_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.131
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Tolerability of a two week treatment with Asasantin extended release 200/25 mg capsules b.i.d, compared to reduced dose during the first week of treatment in a double-blind, randomised, placebo controlled parallel group comparison trial in healthy female and male subjects

    Study Document
    Trial synopsis 9.131_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.136
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Impact of food on pharmacokinetics and pharmacodynamics of Asasantin extended release (ER) 200/25 mg capsules b.i.d. in a randomized, open, 2-way cross-over study in healthy subjects.

    Study Document
    Trial synopsis 9.136_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.138
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Comparison of pharmacokinetics of dipyridamole in Asasantin extended release (ER) 200/25 mg capsules bid and in a combination of Persantin immediate release tablets (100 mg qid) and ASA tablets (25 mg bid) in an open, randomized, 2-way crossover study in healthy subjects.

    Study Document
    Trial synopsis 9.138_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.142
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Mechanism of dipyridamole action in platelets: in-vivo study with healthy volunteers

    Study Document
    Trial synopsis 9.142 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.144
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, 3-way cross-over study to compare the pharmacokinetics of dipyridamole in three different Asasantin ER extended release (ER) 200 mg dipyridamole/25 mg ASA formulations in healthy male and female volunteers.

    Study Document
    Trial synopsis 9.144 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.146
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase IV
    Study Title

    Comparison of pharmacokinetics of dipyridamole administered as Aggrenox® (dipyridamole extended release plus aspirin) capsule versus dipyridamole immediate release plus aspirin following alteration of stomach pH by the prior administration of a proton-pump inhibitor: An open-label 2-way randomized cross-over study in healthy male and female subjects age 40-65.

    Study Document
    Trial synopsis 9.146_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.149
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a new Asasantin capsule formulation (extended release combination 200 mg Dipyridamole/25 mg ASA) compared to the commercially available Asasantin capsule formulation (Aggrenox®; extended release combination 200 mg dipyridamole/25 mg ASA) following multiple oral administration at steady state after a run-inphase (Persantine ER BID for 2 days each: 25 mg, 50 mg, 100 mg; 150 mg [Persantine®]; 200 mg Dipyridamole/25 mg ASA [AsasantinER]) - an open label, randomized, multiple-dose, two-way crossover,change-over study in healthy male and female volunteers.

    Study Document
    Trial synopsis 9.149 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.158
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of dipyridamole after Asasantin (extended release 200 mg dipyridamole/25mg ASA) in 3 experimental formulations (given b.i.d. over 3 or 5 days, respectively) relative to the standard formulation in 16 healthy female and male subjects. Intraindividual comparison, randomised, open.

    Study Document
    Trial synopsis 9.158 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.163
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of dipyridamole of Asasantin p.o. (extended release 200 mg dipyridamole/25 mg ASA) in three experimental formulations (given BID over 3 days each) relative to the standard formulation aftera run-in phase (Persantine ER BID for 2 days each: 25 mg, 50 mg,100 mg; 150 mg [Persantine®]; 200 mg Persantine /25 mg ASA [Asasantin ER] in healthy male subjects. Four-way, change-over,randomised, open

    Study Document
    Trial synopsis 9.163 english
  • ALESION ® - Healthy
    Clinical Study Number 262.252
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    A trial in Healthy Volunteers of the Relative Bioavailability of Epinastine Syrup, a New Galenic Form, compared to the Reference Product Tablets

    Study Document
    Trial synopsis 262.252_CO english
  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.254
    Study Indication Rhinitis, Allergic, Perennial
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase III
    Study Title

    Double-blind, randomised, parallel trial to evaluate the clinical efficacy and safety of Epinastine 10 mg + Pseudoephedrine 120 mg SR, twice a day, versus Epinastine 10 mg alone, twice a day, in the treatment of outpatients with perennial allergic rhinitis

    Study Document
    Trial synopsis 262.254 english
  • ALESION ® - Healthy
    Clinical Study Number 262.255
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    Study of the pharmacokinetic interactions and relative bioavailability of epinastine and pseudoephedrine in healthy volunteers, comparing tablets containing the fixed combination of the two substances with tablets containing each of the two substances separately

    Study Document
    Trial synopsis 262.255_CO english
  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.258
    Study Indication Rhinitis, Allergic, Perennial
    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 Paediatric Perennial Allergic Rhinitis

    Study Document
    Trial synopsis 262.258 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
  • ALESION ® - Healthy
    Clinical Study Number 262.261
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled single increasing dose tolerance study in healthy male volunteers after intranasal application of Epinastine Nasal (dosage: 0.035 mg (0.025% solution)- 0.42 mg (0.3 % solution))

    Study Document
    Trial synopsis 262.261 english
  • ALESION ® - Healthy
    Clinical Study Number 262.284
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 20 mg of the new formulation of WAL 801 CL dry syrup compared to 20 mg of the conventional formulation of WAL 801CL dry syrup following oral administration in healthy male volunteers (an open-label, randomised, single-dose, 2x2 crossover study)

    Study Document
    Trial synopsis 262.284_CO english
  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.290
    Study Indication Rhinitis, Allergic, Perennial
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of Alesion® (epinastine hydrochloride) Tablet

    Study Document
    Trial synopsis 262.290 english
  • ALESION ® - Rhinitis, Allergic, Perennial
    Clinical Study Number 262.293
    Study Indication Rhinitis, Allergic, Perennial
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of Alesion® (epinastine hydrochloride) Dry Syrup - Drug Use - Results Survey of Alesion® Dry Syrup-

    Study Document
    Trial synopsis 262.293 english
  • ALESION ® - Urticaria
    Clinical Study Number 262.294
    Study Indication Urticaria
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance of Alesion® (epinastine hydrochloride) Dry Syrup - Special Drug Use - Results Survey of Aleson® Dry Syrup-

    Study Document
    Trial synopsis 262.294 english
  • Alovudine - HIV Infections
    Clinical Study Number 1211.1
    Study Indication HIV Infections
    Product Alovudine
    Generic Name Alovudine
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, Double Blind, Placebo-controlled Dose Ranging Trial to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure

    Study Document
    Trial synopsis 1211.1 english
  • Amelubant - Healthy
    Clinical Study Number 543.1
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled, parallel-group study to investigate the safety, tolerability, biological effects and preliminary pharmacokinetics of increasing single oral doses of BIIL 284 BS (dose range: 0.025 mg- 75 mg PSE solution, 25 mg, 75 mg, 250 mg and 750 mg WIF tablets) in healthy male volunteers as well as food effects at 75 mg (WIF tablet).

    Study Document
    Trial synopsis 543.1 english
  • Amelubant - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 543.10
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    Effect of 14-Day Treatment with BIIL 284 BS on Patients with COPD (Double-Blind, Placebo-Controlled, Randomised, Parallel Group Study)

    Study Document
    Trial synopsis 543.10_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
  • 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 - Healthy
    Clinical Study Number 543.16
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of Metabolism and Pharmacokinetics of [14C] BIIL 284 BS After Administration of a Single Oral Dose of 25 mg [ 14C] BIIL 284 BS in 6 Healthy Volunteers

    Study Document
    Trial snyopsis 543.16_CO english
  • Amelubant - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 543.17
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    Effect of 12-week treatment of 5, 25 or 75 mg BIIL 284 BS on exercise endurance in patients with chronic obstructive pulmonary disease (double-blind, double dummy, placebo-controlled, randomized, parallel group, dose ranging study)

    Study Document
    Trial synopsis 543.17 english
  • Amelubant - Healthy
    Clinical Study Number 543.24
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    The Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Male Subjects (A randomized, double-blind, placebo-controlled, two period, two-way cross-over study)

    Study Document
    Trial synopsis 543.24_CO english
  • Amelubant - Hepatic Insufficiency
    Clinical Study Number 543.26
    Study Indication Hepatic Insufficiency
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    The Pharmacokinetics, Safety and Tolerability of Single Dose BIIL 284 BS in Patients with Hepatic Impairment in Comparison to Healthy Volunteers (An Open Label, Matched Pair, One Center Study)

    Study Document
    Trial synopsis 543.26 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
  • Amelubant - Healthy
    Clinical Study Number 543.28
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised 4-way cross-over phase I study to investigate the relative bioavailability of BIIL 284 BS 75 mg boli in comparison to tablet C in fasted condition and after ingestion of a standardised meal in healthy volunteers.

    Study Document
    Trial synopsis 543.28 english
  • Amelubant - Healthy
    Clinical Study Number 543.3
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised 3-way cross-over phase I study to investigate the relative bioavailability of BIIL 284 BS 75 mg tablet C and tablet D in comparison to WIF tablet in healthy volunteers.

    Study Document
    Trial synopsis 543.3 english
  • Amelubant - Healthy
    Clinical Study Number 543.31
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised, open-label, two-way crossover study in male healthy volunteers to investigate the relative bioavailability of BIIL 284 BS 5 mg Tablet FF in comparison to Tablet C after ingestion of a standardised meal.

    Study Document
    Trial synopsis 543.31_CO 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
  • Amelubant - Healthy
    Clinical Study Number 543.4
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled, parallel-group study to investigate the safety, tolerability, biological effects and preliminary pharmacokinetics of increasing repeated oral doses (9 days dosing) of BIIL 284 BS (doses: 25 mg, 150 mg, 250 mg as WIF tablets) in healthy male volunteers.

    Study Document
    Trial synopsis 543.4 english
  • Amelubant - Healthy
    Clinical Study Number 543.5
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised 3-way cross-over phase I study to investigate the effect of different food compositions (low fat and high fat meal) on bioavailability of BIIL 284 BS 75 mg tablet in healthy male volunteers.

    Study Document
    Trial synopsis 543.5 english
  • Amelubant - Healthy
    Clinical Study Number 543.7
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    The Effects of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of a Single Dose of Theophylline in Healthy Male Volunteers (A Randomized, Double-Blind, Placebo­ Controlled, Two-period, Two-way Crossover Study)

    Study Document
    Trial synopsis 543.7_CO english
  • ANTISTAX ® - Venous Insufficiency
    Clinical Study Number 1138.10
    Study Indication Venous Insufficiency
    Product ANTISTAX ®
    Generic Name Vitis vinifera
    Lab Code
    Clinical Phase III
    Study Title

    A 12-week, double-blind, randomised, placebo-controlled, multicentre trial to evaluate efficacy and tolerability of Antistax® film-coated tablets, 360 mg/day orally, in male and female patients suffering from chronic venous insufficiency

    Study Document
    Trial synopsis 1138.10_CO english
  • ANTISTAX ® - Venous Insufficiency
    Clinical Study Number 1138.11
    Study Indication Venous Insufficiency
    Product ANTISTAX ®
    Generic Name Vitis vinifera
    Lab Code
    Clinical Phase III
    Study Title

    A 12-week, double-blind, randomised, placebo-controlled, multicentre trial to evaluate efficacy and tolerability of Antistax® film coated tablets, 720 mg/day orally, in male and female patients suffering from chronic venous insufficiency

    Study Document
    Trial synopsis 1138.11_DR english
  • ANTISTAX ® - Venous Insufficiency
    Clinical Study Number 1138.2
    Study Indication Venous Insufficiency
    Product ANTISTAX ®
    Generic Name Vinitis vinifera
    Lab Code
    Clinical Phase II
    Study Title

    The ability of Antistax® to improve Chronic Venous Insufficiency (CVI) I and II in male and female patients: a dose response study

    Study Document
    Trial synopsis 1138.2 english
  • ANTISTAX ® - Venous Insufficiency
    Clinical Study Number 1138.3
    Study Indication Venous Insufficiency
    Product ANTISTAX ®
    Generic Name Vinitis vinifera
    Lab Code
    Clinical Phase II
    Study Title

    A 17 week, randomised, double-blind, placebo controlled cross-over trial to evaluate the efficacy of Antistax ® film coated tablets (Extr. Vitis vinitera siccum), 360 mg/day p.o. in improving microcirculation of the skin in the leg of male and female patients suffering trom chronic venous insufficiency

    Study Document
    Trial synopsis 1138.3 english
  • ANTISTAX ® - Venous Insufficiency
    Clinical Study Number 1138.4
    Study Indication Venous Insufficiency
    Product ANTISTAX ®
    Generic Name Vinitis vinifera
    Lab Code
    Clinical Phase III
    Study Title

    A 12-week, double-blind, randomised, placebo-controlled, multicentre trial to evaluate efficacy and tolerability of Antistax® film coated tablets, 360 mg/day orally, in male and female patients suffering from chronic venous insufficiency

    Study Document
    Trial synopsis 1138.4 english
  • ANTISTAX ® - Venous Insufficiency
    Clinical Study Number 1138.5
    Study Indication Venous Insufficiency
    Product ANTISTAX ®
    Generic Name Vinitis vinifera
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A 6-week, open, multicentre safety trial to evaluate the tolerability profile of Antistax® film coated tablets (extr. Vitis viniferae siccum), 360 mg/day per os, in male and female patients suffering from chronic venous insufficiency

    Study Document
    Trial synopsis 1138.5 english
  • ANTISTAX ® - Venous Insufficiency
    Clinical Study Number 1138.6
    Study Indication Venous Insufficiency
    Product ANTISTAX ®
    Generic Name Vinitis vinifera
    Lab Code
    Clinical Phase III
    Study Title

    Clinical Study of BNS003 on Swelling due to Disorder of Leg Venous Reflux

    Study Document
    Trial synopsis 1138.6_CO english
  • ANTISTAX ® - Healthy
    Clinical Study Number 1138.9
    Study Indication Healthy
    Product ANTISTAX ®
    Generic Name Vinitis vinifera
    Lab Code
    Clinical Phase I
    Study Title

    An open, uncontrolled trial in healthy volunteers to explore the plasma and urinary pharmacokinetics of a single oral dose of 1,800 mg Red Vine Leaf Extract (Antistax®)

    Study Document
    Trial synopsis 1138.9_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.14
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I/IIa
    Study Title

    Multiple-dose, open-label, randomized, safety and pharmacokinetic study of tipranavir in combination with low-dose ritonavir in HIV-infected pediatric patients

    Study Document
    Trial synopsis 1182.14 english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.12
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase III
    Study Title

    Randomized, open-label, comparative safety and efficacy study of tipranavir boosted with low-dose ritonavir (TPV/RTV) versus genotypically-defined protease inhibitor/ritonavir (PI/RTV) in multiple antiretroviral drug-experienced patients (RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir)

    Study Document
    Trial synopsis 1182.12_DS_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.127
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IV
    Study Title

    An observational study of HIV-1 infected adult patients treated with combination antiretroviral therapy including APTIVUS®

    Study Document
    Trial synopsis 1182.127_DR english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.16
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    An Open Label Safety Study of Tipranavir Co-administered with low-dose Ritonavir (TPV/r) in patients with advanced HIV-1 infection and limited treatment options.

    Study Document
    Trial synopsis 1182.16_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.17
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase II/III
    Study Title

    A long-term open-label rollover trial assessing the safety and tolerability of combination tipranavir and ritonavir use in HIV-1 infected patients

    Study Document
    Trial synopsis 1182.17_DS_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.2
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase II
    Study Title

    Tipranavir disodium: An Open-Label Exploratory Study of Tipranavir and Ritonavir in Combination with One Nucleoside Reverse Transcriptase Inhibitor an One None-Nucleoside Reverse Transcriptase Inhibitor in Multiple Protease Inhibitor- Experienced HIV Patients.

    Study Document
    Trial synopsis 1182.2_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.33
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIb, III
    Study Title

    A randomised, open label, active controlled trial to evaluate the antiviral efficacy and safety of treatment with 500 mg Tipranavir plus 100 mg or 200 mg Ritonavir p.o. BID in combination with standard background regimen in comparison to 400 mg Lopinavir plus 100 mg Ritonavir p.o. BID in combination with standard background regimen in antiretroviral therapy naive patients for 48 with extension up to 156 weeks.

    Study Document
    Trial statement 1182.33_CO english
    Trial synopsis 1182.33_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.48
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase III
    Study Title

    Randomized, open-label, comparative safety and efficacy study of tipranavir boosted with low dose ritonavir (TPV/RTV) versus genotypically-defined protease inhibitor/ritonavir (PI/RTV) in multiple antiretroviral drug-experienced patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir)

    Study Document
    Trial synopsis 1182.48_PE_DR english
    Trial synopsis 1182.48_DS_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.51
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase II
    Study Title

    An open label, randomized, parallel-group pharmacokinetics trial of tipranavir / ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV), or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced patients.

    Study Document
    Trial synopsis 1182.51_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.52
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIb
    Study Title

    Double-blind, randomized, dose optimization trial of three doses of tipranavir boosted with low dose ritonavir (TPV/RTV) in multiple antiretroviral drug-experienced subjects

    Study Document
    Trial synopsis 1182.52_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.67
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    Expanded Access Program France

    Study Document
    Trial synopsis 1182.67_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.68
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    An Open Label Safety Study of Tipranavir Co-administered with Low-dose Ritonavir (TPV/r) in Patients with Advanced HIV-1 Infection and Limited Treatment Options

    Study Document
    Trial synopsis 1182.68_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.70
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    An open label, non-randomized treatment protocol of Tipranavir co-administered with low-dose Ritonavir (TPV/r) in protease inhibitor-experienced patients with HIV-1 infection (the Tipranavir Expanded Access Program)

    Study Document
    Trial synopsis 1182.70_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.71
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    A prospective, randomized, open-labelled, multi-centre trial comparing the safety and efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to that of Prezista® (Darunavir, DRV/r) in three-class (NRTI, NNRTI, and PI) treatment-experienced patients with resistance to more than one PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients

    Study Document
    Trial statement 1182.71_CO english
    Trial synopsis 1182.71_DR english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.98
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir (TPV/r) 500 mg/200 mg BID IN a racially and Gender diverse HIV-positive treatment experienced population with a pilot evaluation of therapeutic drug monitoring (TDM). The SPRING study is an open-label, multicenter, multinational trial with randomisation to standard of care (SOC) or TDM TPV/r therapy

    Study Document
    Trial statement 1182.98_CO english
    Trial synopsis 1182.98_DR english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.99
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIIb
    Study Title

    Safety and efficacy study of TIpranavir boosted with low dose ritonavir (TPV/r) 500/200mg BID in antiretroviral treatment experienced HIV positive patients with HCV or HBV Co-INfection, with a pilot evaluation of therapeutic drug monitoring (TDM). An Open-label, multicenter, multinational trial with randomisation to standard of care (SOC) or TDM TPV/r therapy (TICINO)

    Study Document
    Trial synopsis 1182.99_DR english
    Trial statement 1182.99_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.107
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IIb
    Study Title

    A multicenter, randomized, open label, clinical trial to evaluate three doses of tipranavir boosted with ritonavir (500 mg/200 mg qd, 250 mg/100 mg bid and 500 mg/100 mg bid) by assessing the steady-state pharmacokinetics and short-term efficacy and safety in HIV-1 positive treatment naive patients

    Study Document
    Trial synopsis 1182.107_DR english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.112
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IV
    Study Title

    Non-interventional observational study of antiretroviral combination therapy with Aptivus® (tipranavir) and low-dose Norvir® (ritonavir) in HIV-infected patients

    Study Document
    Trial synopsis 1182.112_DR english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.147
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase IV
    Study Title

    PMS assessing the long-term efficacy and safety of tipranavir (Aptivus®) co-administered with low-dose ritonavir in treatment experienced patients with HIV-1 infection in the daily clinical practice.

    Study Document
    Trial synopsis 1182.147_DR english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.10
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single centre, open-label study, in healthy adult volunteers, to determine the effects of single-dose and steady-state TPV/RTV500/200 mg on the steady-state pharmacokinetics of fluconazole100 mg qd (200 mg loading dose)

    Study Document
    Trial synopsis 1182.10_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.100
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, single-site, one-sequence cross-over study to assess the Relative Bioavailability of TPV/r 500 mg/200 mg at steady state whenTPV and RTV are administered as oral solutions vs. capsules in the fed and fasted state

    Study Document
    Trial synopsis 1182.100_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.101
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Evaluating the effects of Tipranavir (with ritonavir) capsule and liquid formulation on cytochrome P450 and P-glycoprotein activity using a biomarker cocktail in healthy human volunteers

    Study Document
    Trial synopsis 1182.101_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.102
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre, open-label study to assess the effects of steady-state Efavirenz 600 mg QD (Sustiva®) on Tipranavir concentration whenTipranavir/Ritonavir are administered at doses 500 mg/200 mg BID to steady-state in healthy adult volunteers

    Study Document
    Trial synopsis 1182.102_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.104
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label one-sequence cross-over pharmacokinetic interaction study of steady-state tipranavir/ritonavir 500/200 mg with single-dose valaciclovir (500 mg) in healthy volunteers

    Study Document
    Trial synopsis 1182.104_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.109
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I/IIa
    Study Title

    Effect of steady state TPV/r 500 mg/200 mg on intracellular concentrations of zidovudine triphosphate and carbovir triphosphate

    Study Document
    Trial synopsis 1182.109_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.11
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre open-label study in healthy adult volunteers to determine the effects of single-dose and steady-state TPV/r(500 mg/200 mg) on the steady-state pharmacokinetics of Clarithromycin (BIAXIN ®) 500 mg bid and a preliminary assessment of the effects of a standard high-fat test meal on the steady-state pharmacokinetics of Tipranavir

    Study Document
    Trial synopsis 1182.11_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.117
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Effects of steady state Tipranavir/ritonavir or Darunavir/ritonavir or Ritonaviron platelet function, coagulation and fibrinolysis biomarkers in healthy subjects

    Study Document
    Trial synopsis 1182.117_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.124
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of two different oral solutions of 500 mg of tipranavir (new formulation vs. current formulation) administered in combination with 200 mg of ritonavir (oral solution) to healthy volunteers (an open-label, randomised,single-dose, two-way crossover study)

    Study Document
    Trial synopsis 1182.124 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.21
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Two-way Pharmacokinetic Interaction Study of Single-Dose Atorvastatin (LIPITOR®) with Tipranavir/Ritonavir (500 mg/200 mg) at Steady-State and the Effect of Antacid (MAALOX®) on the Pharmacokinetics of Single-Dose Tipranavir/Ritonavir(500 mg/200 mg) in Healthy Volunteers

    Study Document
    Trial synopsis 1182.21_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.22
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single centre, open-label, randomized, parallel group, multiple dose comparison of the effect of Tipranavir 750 mg and Ritonavir 200 mg or Tipranavir 500 mg and Ritonavir 100 mg, administered twice daily, on the pharmacokinetic characteristics of Norethindrone-Ethinyl Estradiol (Ortho®-1/35) administered as a single dose, in healthy female adult volunteers

    Study Document
    Trial synopsis 1182.22_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.24
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I multiple oral dose trial of Tipranavir 500 mg/Ritonavir200 mg dosed to steady-state followed by single-dose14C-radiolabeled Tipranavir co-administered with Tipranavir 500 mg/Ritonavir 200 mg to characterize the excretion balance and metabolite profile of 14C-radiolabeled Tipranavir in healthy male subjects

    Study Document
    Trial synopsis 1182.24_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.26
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre, open-label study of multiple doses of tipranavir 500 mg and ritonavir 200 mg (twice daily) on the pharmacokinetic characteristics of methadone administered as a single dose in healthy volunteers.

    Study Document
    Trial synopsis 1182.26_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.3
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase II
    Study Title

    PNU-140690: A fourteen day dose-response study using a prototype self-emulsifying drug delivery sustem (SEDDS) formulation in treatment-naive HIV-1 infected patients.

    Study Document
    Trial synopsis 1182.3 english
  • APTIVUS ® - Hepatic Insufficiency
    Clinical Study Number 1182.32
    Study Indication Hepatic Insufficiency
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label study to determine the pharmacokinetics of single-dose and/or steady-state TPV/r 500/200 mg in subjects with mild and moderate hepatic insufficiency 

    Study Document
    Trial synopsis 1182.32 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.42
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open label, randomised, parallel group study of the drug-drug pharmacokinetic interaction of steady state tipranavir (SEDDS SEC) 500 mg and ritonavir (soft gelatin capsules) 100 mg or tipranavir750 mg and ritonavir 200 mg, both bid for 13.5 days with single dose didanosine 400 mg (delayed release capsule EC beadlets) in healthy volunteers

    Study Document
    Trial synopsis 1182.42 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.44
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre open-label study in healthy adult volunteers to determine the effects of steady-state TPV/r (500 mg/200 mg) on the single-dose pharmacokinetics of rifabutin (MYCOBUTIN®) 150 mg, and the effects of single-dose rifabutin (150mg) on the steady-state pharmacokinetics ofTPV 500 mg (co-administered with RTV 200 mg)

    Study Document
    Trial synopsis 1182.44_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.45
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 500/200 mg of tipranavir/ritonavir paediatric solution compared to 500/200 mg of tipranavir/ritonavir capsules following oral administration and bioavailability of 500/200 mg tipranavir/ritonavir paediatric solution under the influence of food in healthy female and male subjects. An open-label, randomised,single-dose, three-way crossover trial.

    Study Document
    Trial synopsis 1182.45 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.46
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Single Centre, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effects of Tipranavir 500 mg and Ritonavir 100 mg r Tipranavir 750 mg and Ritonavir 200 mg twice a day for 11.5 dayson the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate 300 mg in Healthy Volunteers

    Study Document
    Trial synopsis 1182.46_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.5
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An Open-label, Parallel Group, Multiple-dose Investigation of the Pharmacokinetics of Tipranavir Soft Elastic Capsules SEDDS and Ritonavir Soft Gel Capsules and Their Effects on Cytochrome P-450 (3A4) Activity in Normal Healthy Volunteers

    Study Document
    Trial synopsis 1182.5_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.55
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    The pharmacodynamic/pharmacokinetic interaction of tipranavir and ritonavir with loperamide in healthy volunteers

    Study Document
    Trial synopsis 1182.55_CO english
  • APTIVUS ® - Hepatitis C
    Clinical Study Number 1182.59
    Study Indication Hepatitis C
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Open label, study to determine the pharmacokinetic interactions of steady state tipranavir/ritonavir (500/200 mg) and steady state ribavirin and pegylated Interferon alfa 2a in HIV negative, HCV infected subjects with mild hepatic impairment and the pharmacokinetic properties of tipranavir/ritonavir in HIV negative, HCV, HBV, hepatitis delta infected subjects or alcoholic cirrhosis subjects with moderate hepatic impairment

    Study Document
    Trial synopsis 1182.59 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.60
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of electrophysiological effects of tipranavir co-administered with ritonavir given b.i.d. for 2.5 days on the QT interval in healthy female and male subjects. A double-blind, randomised, placebo controlled, two-way crossover study with a positive control (moxifloxacin) and parallel dose roups

    Study Document
    Trial synopsis 1182.60_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.61
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre open-label study in healthy adult volunteers to assess the pharmacokinetic interactions between steady-state TPV (500 mg) and single-dose and steady-state atazanavir (300 mg QD) in the presence of ritonavir (100 mg)

    Study Document
    Trial synopsis 1182.61_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.80
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single centre, open-label study with healthy adult volunteers to determine the effects of single-dose and steady-state TPV/r 500/200 mg on the steady-state pharmacokinetics of carbamazepine (200 mg twice daily)

    Study Document
    Trial synopsis 1182.80_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.83
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of single-dose oral tadalafil pharmacokinetic characteristics when simultaneously co-administered with single-doseand steady-state tipranavir/ritonavir 500 mg/200 mg to healthy male volunteers

    Study Document
    Trial synopsis 1182.83_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.84
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre, open-label study in healthy adult volunteers to determine the effects of multiple-dose omeprazole (ANTRA® 40 mgqd) on the single-dose pharmacokinetics of tipranavir 500 mg coadministered with ritonavir 200 mg

    Study Document
    Trial synopsis 1182.84_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.93
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomized, single-dose, two-way crossover bioequivalence study assessing subjects receiving tipranavir 500 mg storedat controlled temperature (test product 30°C/70% RH) compared with tipranavir 500 mg stored at controlled refrigerated conditions (reference product 2-8°C), orally co-administered with ritonavir 200 mg under fasting conditions to healthy male and female volunteers

    Study Document
    Trial synopsis 1182.93_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.4
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase II
    Study Title

    Tipranavir: An open-label, randomized study comparing combination therapy (Tipranavir and Ritonavir vs. Saquinavir and Ritonavir) used with two nucleoside reverse transcriptase inhibitors in single protease inhibitor-experienced HIV-1 patients

    Study Document
    Trial synopsis 1182.4_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.41
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Single Center, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effect of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg, Administered Daily on 3 Non-Consecutive Days and Twice Daily for 7 Days, on the Pharmacokinetic Characteristics of Efavirenz (Sustiva®) 600 mg a Day in Healthy Adult Volunteers

    Study Document
    Trial synopsis 1182.41_CO english
  • APTIVUS ® - HIV Infections
    Clinical Study Number 1182.6
    Study Indication HIV Infections
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I/IIa
    Study Title

    An open-label multinational study of the effects of three dose pairs of tipranavir/ritonavir (b.i.d.) on the pharmacokinetic characteristics of protocoldefined, baseline, triple drug nucleoside and non-nucleoside reverse transcriptaseinhibitor therapy in HIV-1 infected subjects

    Study Document
    Trial synopsis 1182.6 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.37
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Single Center, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effect of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg twice a day for 11.5 days on the Pharmacokinetic Characteristics of Zidovudine 300 mg in Healthy Volunteers

    Study Document
    Trial synopsis 1182.37_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2502
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance (as per § 67 (6) AMG [German Drug Law]) of Atrovent® inhalets in Chronic Obstructive Pulmonary Disease

    Study Document
    Trial synopsis 244.2502_CO 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
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2507
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    ATROVENT HFA open-label Actuation Indicator evaluation and handling study in Adults with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document
    Trial synopsis 244.2507_DS_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2496
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (as per § 67 (6) AMG [German Drug Law]) of Atrovent® in long-term therapy in Chronic Obstructive Pulmonary Disease

    Study Document
    Trial synopsis 244.2496_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2500
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance study (as per § 67 (6) AMG [German Drug Law]) of Atrovent® 500 µg/2 ml inhalation solution in Chronic Obstructive Pulmonary Disease

    Study Document
    Trial synopsis 244.2500_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2501
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (as per § 67 (6) AMG [German Drug Law]) of Atrovent® inhalets in Chronic Obstructive Pulmonary Disease

    Study Document
    Trial synopsis 244.2501_CO 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
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2480
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    An Open-Label, Crossover, Pharmacokinetic Trial to Determine the Comparability of 84 mcg Ipratropium Bromide HFA-134a Inhalation Aerosol to 84 mcg ATROVENT® CFC  Inhalation Aerosol, in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document
    Trial synopsis 244.2480_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2484
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A six month, double-blind (within formulation), randomized, multiple dose trial to compare the safety and efficacy of 20 mcg and 40 mcg of ipratropium bromide, as delivered by the Respimat® device, to 18 mcg ATROVENT® Inhalation Aerosol (x 2 puffs) and respective placebos in adults, with chronic obstructive pulmonary disease

    Study Document
    Trial synopsis 244.2484 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2489
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Double-Blind, Placebo Controlled Trial to Assess the Safety of Two-Week Administration of 80 Mcg Q.I.D. and 160 Mcg Q.I.D. of Ipratropium Bromide, as Delivered by the RESPIMAT® Device, in Patients with Chronic Obstructive Pulmonary Disease

    Study Document
    Trial synopsis 244.2489_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2491
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG [German Drug Law]) of Atrovent® Inhaletten® in chronic obstructive airways disease

    Study Document
    Trial synopsis 244.2491 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2492
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG [German Drug Law]) of Atrovent® Inhaletten® in chronic obstructive airways disease

    Study Document
    Trial synopsis 244.2492 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2493
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG [German Drug Law]) of Atrovent® unit dose vial 500 mvg in chronic obstructive airways disease

    Study Document
    Trial synopsis 244.2493 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2497
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with § 67 (6) AMG) of Atrovent® inhalets in Chronic Obstructive Pulmonary Disease

    Study Document
    Trial synopsis 244.2497 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2498
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Single-Dose, Double Blind, Crossover Trial to Determine the Comparability of Ipratropium Bromide HFA-134a Inhalation Aerosol to the Market Standard, ATROVENT® CFC Inhalation Aerosol, in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document
    Trial synopsis 244.2498_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2499
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with § 67 (6) AMG) of anticholinergics -prescribing pattern and therapeutic long-term value in patients suffering from moderate or severe Chronic Obstructive Pulmonary Disease

    Study Document
    Trial synopsis 244.2499 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2514
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Peri-operative intervention with nebulized ipratropium bromide in Chinese patients with chronic obstructive pulmonary disease (COPD): a randomised, double-blind, placebo-controlled, parallel-group, multicentre trial

    Study Document
    Trial synopsis 244.2514_DR english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.1
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacodynamics and pharmacokinetics of single rising inhaled BEA 2180 BR doses (2.5 µg to 1600 µg administered with the Respimat®) in healthy male subjects, alone and followed by methacholine challenge. A randomised, double-blind within dose group, placebo-controlled study, with a 36 µg tiotropium bromide single dose sub-study (open, two-fold crossover).

    Study Document
    Trial synopsis 1205.1_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.2
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising inhalative doses (20 µg, 50 µg, 100 µg, 200 µg, and 400 µg) of BEA 2180 BR for 21 days in healthy male volunteers (double-blind, randomised, placebo controlled [at each dose level] study)

    Study Document
    Trial synopsis 1205.2_CO english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.3
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, Double-Blind, Placebo-Controlled, 4-Way Cross-Over Study to Assess the Efficacy and Safety of a Single Dose of Orally Inhaled BEA 2180 BR (doses 80, 200 and 800 µg) in COPD Patients Followed by an Open-Label, Active-Control (tiotropium 72 µg)

    Study Document
    Trial synopsis 1205.3_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.5
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, single-blind, placebo-controlled (within dose groups) study to assess safety, tolerability and pharmacokinetics of single rising intravenous doses (2.5 µg, 7.5 µg, 25 µg, 50 µg, 100 µg, 200 µg, 350 µg, 500 µg free cation) BEA 2180 BR in healthy male volunteers with an additional arm by inhalation in one dose group (1600 µg)

    Study Document
    Trial synopsis 1205.5 english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.8
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the metabolism and pharmacokinetics of 1200 µg (free cation)[14C] BEA 2180 BR administered orally compared to 500 µg (free cation) [14C] BEA 2180 BR administered intravenously in healthy male volunteers in an open label, single-dose and parallel study design

    Study Document
    Trial synopsis 1205.8_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.18
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled (within dose groups) study to evaluate safety, tolerability and pharmacokinetics of multiple rising inhalative doses (50 µg, 100 µg and 200 µg q.d. for 14 days) of BEA 2180 BR in Japanese healthy male volunteers

    Study Document
    Trial synopsis 1205.18_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.20
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, single-blind, placebo-controlled (within dose groups) study to assess safety, tolerability and pharmacokinetics of single rising peroral doses (400, 800, 1200 µg free cation) BEA 2180 BR in healthy male volunteers.

    Study Document
    Trial synopsis 1205.20_CO english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.14
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIb
    Study Title

    A multinational, randomized, double-blind, placebo- and active-controlled, parallel group efficacy and safety comparison over 24 weeks of three doses (50 µg , 100 µg, 200 µg) of BEA 2180 to tiotropium 5 µg and placebo deliveredby the Respimat® inhaler in patients with chronic obstructive pulmonary disease (COPD)

    Study Document
    Trial synopsis 1205.14_DR english
    Pooled analysis 1205.14_DR english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.4
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomized, multiple-dose, double-blind, placebo- and active controlled, parallel group efficacy and safety study to determine the optimum dose of BEA 2180 BR delivered by the Respimat® inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document
    Trial synopsis 1205.4_DR english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.6
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIb
    Study Title

    A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 µg and 400 µg of BEA 2180 BR to Tiotropium 5 µg and Placebo When Each is Delivered by the Respimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document
    Trial synopsis 1205.6_DR english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1365
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised open label, four way, cross-over scintigraphic evaluation of the Respimat® inhaler vs. a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic Obstructive Pulmonary disease (COPD) with poor MDI technique.

    Study Document
    Trial synopsis 215.1365_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1364
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised open label, six way, cross-over scintigraphic evaluation of the effect of inspiratory flow rate on lung and oropharyngeal deposition with the Respimat® inhaler vs. a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic Obstructive Pulmonary disease (COPD).

    Study Document
    Trial synopsis 215.1364 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
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1349
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, placebo-controlled, within-device, double-blind tri-national study to compare the safety and efficacy of Berodual® administered via the Respimat® device (50 mcg fenoterol hydrobromide/20 mcg ipratropium bromide and 25 mcg fenoterol hydrobromide/10mcg 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 COPD patients over a 12-week period.

    Study Document
    Trial synopsis 215.1349 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1352
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Postrnarketing surveillance study (as per§ 67 (6) AMG [German DrugLaw]) of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease

    Study Document
    Trial synopsis 215.1352 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1353
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with§ 67,6 AMG) of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease

    Study Document
    Trial synopsis 215.1353 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1357
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    Berodual® Respimat® Inhaler (20g ipratropium bromide/50g fenoterol hydrobromide, 1 actuation t.i.d./q.i.d.) versus Berodual® MA using HFA 134a as propellant (20g ipratropium bromide (anhydrous)/50g fenoterol hydrobromide, 2 puffs t.i.d./q.i.d.) in adult patients with asthma, chronic obstructive pulmonary disease, or mixed conditions, an open-label, crossover trial over a 7-week treatment period with each formulation:"A Study To Compare Patient Preference"

    Study Document
    Trial synopsis 215.1357_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1358
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with § 67 (6) AMG) of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease

    Study Document
    Trial synopsis 215.1358 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1360
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A randomised open label, four way, cross-over scintigraphic evaluation of the Respimat® inhaler vs a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic Obstructive Pulmonary Disease(COPD) with poor MDI technique

    Study Document
    Trial synopsis 215.1360_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1361
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A randomised open label, six way, cross-over scintigraphic evaluation of the effect of inspiratory flow rate on lung and oropharyngealde position with the Respimat® inhaler vs a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic ObstructivePulmonary Disease (COPD)

    Study Document
    Trial synopsis 215.1361_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1362
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50 mcg/dose solution for inhalation in patients with chronic obstructive airways disease

    Study Document
    Trial synopsis 215.1362 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1363
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease

    Study Document
    Trial synopsis 215.1363 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1366
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50 mcg/dose solution for inhalation: Assessment of handling and patient satifaction in comparison to a powder inhaler

    Study Document
    Trial synopsis 215.1366 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1367
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50 mcg/dose solution for inhalation: Assessment of handling and patient satifaction

    Study Document
    Trial synopsis 215.1367 english
  • BEROTEC ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 260.3178
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEROTEC ®
    Generic Name Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG [German Drug Law]) of Berotec® N 100 mcg meterd-dose inhaler in chronic obstructive airways disease

    Study Document
    Trial synopsis 260.3178 english
  • BI 1015550 - Healthy
    Clinical Study Number 1305.1
    Study Indication Healthy
    Product BI 1015550
    Generic Name BI 1015550
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 1015550 in healthy male volunteers (a partially randomised, partially single-blind, placebo-controlled phase I study)

    Study Document
    Trial synopsis 1305.1_DS english
  • BI 1015550 - Healthy
    Clinical Study Number 1305.2
    Study Indication Healthy
    Product BI 1015550
    Generic Name BI 1015550
    Lab Code BI 1015550
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising oral doses of BI 1015550 powder for oral solution in healthy male volunteers q.d. or b.i.d.for 14 days (a randomised, double-blind, placebo-controlled within dose groups Phase I trial)

    Study Document
    Trial synopsis 1305.2 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
  • BI 1026706 - Healthy
    Clinical Study Number 1320.1
    Study Indication Healthy
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 1026706 in healthy male volunteers in a partially randomised, single-blind, placebo-controlled trial, and investigation of relative bioavailability of BI 1026706 (open-label, randomised, 4-way cross-over)

    Study Document
    Trial synopsis 1320.1 english
  • BI 1026706 - Healthy , Osteoarthritis
    Clinical Study Number 1320.2
    Study Indication Healthy ; Osteoarthritis
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses of BI 1026706 in male and female healthy subjects and patients with osteoarthritis of the knee (randomised, double-blind, placebo-controlled within the dose groups, clinical phase I)

    Study Document
    Trial synopsis 1320.2 english
  • BI 1026706 - Healthy
    Clinical Study Number 1320.3
    Study Indication Healthy
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    Effectiveness of two different doses of BI 1026706 on the overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory, radiant-heat) evoked potentials (LEP) in UVB (ultraviolet)-irradiated skin in healthy male volunteers (a single-blinded, randomised, placebo-controlled, single-dose, five-way crossover study)

    Study Document
    Trial synopsis 1320.3 english
  • BI 1026706 - Pain, Postoperative
    Clinical Study Number 1320.13
    Study Indication Pain, Postoperative
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I/IIa
    Study Title

    Effectiveness and safety of different doses of BI 1026706 in patients with postoperative dental pain (a single-centre, partially double-blinded, randomised, placebo- and active comparator-controlled, single-dose, parallelgroup study)

    Study Document
    Trial synopsis 1320.13 english
  • BI 1026706 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1320.16
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase Ic
    Study Title

    A Phase I randomized, double-blind, placebo-controlled, parallel-group trial of BI 1026706 administered orally as tablets twice daily for 4 weeks to patients with COPD in order to evaluate safety, tolerability, pharmacokinetics and effect on inflammation

    Study Document
    Trial synopsis 1320.16 english
  • BI 1026706 - Healthy
    Clinical Study Number 1320.17
    Study Indication Healthy
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    A randomized, double-blind, placebo-controlled, parallel group, Phase I trial in healthy current smoker subjects to assess pharmacodynamic effects on segmental endotoxin induced inflammatory response and safety of 4 weeks oral administration of BI 1026706

    Study Document
    Trial synopsis 1320.17 english
  • BI 1026706 - Healthy
    Clinical Study Number 1320.20
    Study Indication Healthy
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    Effect of multiple doses of itraconazole on the pharmacokinetics of a single oral dose of BI 1026706 in healthy male subjects (an open-label, randomised, twoperiod, two-sequence crossover study)

    Study Document
    Trial synopsis 1320.20 english
  • BI 1026706 - Healthy
    Clinical Study Number 1320.23
    Study Indication Healthy
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses and multiple oral doses of BI 1026706 in healthy Chinese and Japanese male volunteers (randomised, double-blind, placebo-controlled trial)

    Study Document
    Trial synopsis 1320.23 english
  • BI 1034020 - Healthy
    Clinical Study Number 1312.1
    Study Indication Healthy
    Product BI 1034020
    Generic Name BI 1034020
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising intravenous and subcutaneous doses of BI 1034020 in healthy male volunteers (partially randomised, single-blind, placebo-controlled within dose groups, clinical phase I study)

    Study Document
    Trial statement 1312.1_DR english
    Trial synopsis 1312.1_DR english
  • BI 11054 - Healthy
    Clinical Study Number 1250.1
    Study Indication Healthy
    Product BI 11054
    Generic Name BI 11054
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled (within dose groups) study to assess safety, tolerability, and pharmacokinetics of single rising inhaled doses (0.5 µg to 70 µg administered with Respimat®) of BI 11054 CL in healthy male volunteers

    Study Document
    Trial synopsis 1250.1 english
  • BI 113608 - Healthy
    Clinical Study Number 1314.1
    Study Indication Healthy
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 113608 in healthy male volunteers (randomised, double-blind, placebo-controlled within dose groups)

    Study Document
    Trial synopsis 1314.1_DS english
  • BI 113608 - Healthy
    Clinical Study Number 1314.2
    Study Indication Healthy
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 powder for oral solution in healthy male volunteers q.d. or b.i.d. for 14 days (a randomised, double-blind, placebo-controlled within dose groups Phase I trial)

    Study Document
    Trial synopsis 1314.2 english
  • BI 113608 - Healthy
    Clinical Study Number 1314.3
    Study Indication Healthy
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    An open label, randomised, single dose, 3-way cross over study to investigate relative bioavailability and food effect on different formulations of BI 113608 in healthy male subjects, followed by fixed sequence periods investigating influence of pantoprazole coadministration and food effect on pharmacokinetics of different formulations of BI 113608

    Study Document
    Trial synopsis 1314.3 english
  • BI 113608 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1314.5
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    Randomized, placebo-controlled, double-blind within dose groups, multiple rising-dose study to evaluate safety, tolerability, and PK of oral BI 113608 administered as tablets twice daily over 4 weeks in patients with COPD associated with chronic bronchitis

    Study Document
    Trial synopsis 1314.5 english
  • BI 113608 - Healthy
    Clinical Study Number 1314.7
    Study Indication Healthy
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    Relative bioavailability of single oral dose of BI 113608 when administered alone or in combination with multiple oral doses of ketoconazole or voriconazole in healthy male subjects (an open-label, randomised, three-period cross-over trial)

    Study Document
    Trial synopsis 1314.7 english
  • BI 113608 - Healthy
    Clinical Study Number 1314.9
    Study Indication Healthy
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses and multiple rising oral doses of BI 113608 in healthy male Asian and Caucasian volunteers (randomised, double-blind, placebo-controlled within dose groups)

    Study Document
    Trial synopsis 1314.9 english
  • BI 113823 - Healthy
    Clinical Study Number 1272.1
    Study Indication Healthy
    Product BI 113823
    Generic Name BI 113823
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of safety, tolerability and pharmacokinetics of single rising oral doses of 5 to 800 mg BI 113823 Powder in Bottle (PiB) and tablet administered to healthy male volunteers in a partially randomised and double-blinded, placebo-controlled phase I trial. Including intra-individual open comparisons of PiB and tablet (fasted and fed)

    Study Document
    Trial synopsis 1272.1_CO english
  • BI 11634 - Healthy
    Clinical Study Number 1234.1
    Study Indication Healthy
    Product BI 11634
    Generic Name BI 11634
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of 5, 10, 25, 50, 100, 200 and 400 mg BI 11634 solution administered to healthy male volunteers. Randomised, double-blind, placebo controlled at each dose level. Intra-individual comparison of solution to an immediate release tablet formulation at one dose level (50mg)

    Study Document
    Trial synopsis 1234.1_CO english
  • BI 11634 - Healthy
    Clinical Study Number 1234.12
    Study Indication Healthy
    Product BI 11634
    Generic Name BI 11634
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 10 mg BI 11634 immediate release tablet (IR) compared to 10 mg of oral solution following oral administration in healthy male volunteers (open-label, single-dose, intra-individual comparison); determination of pharmacokinetics of 5 mg, 10 mg and 25 mg IR-tablet formulation (open-label, single dose)

    Study Document
    Trial synopsis 1234.12_CO english
  • BI 11634 - Healthy
    Clinical Study Number 1234.2
    Study Indication Healthy
    Product BI 11634
    Generic Name BI 11634
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple, rising oral doses of 2.5 mg, 5 mg, 7.5 mg, and 10 mg BI 11634 oral solution administered t.i.d. for 5 days to healthy male volunteers; randomised, double-blind, placebo-controlled at each dose level

    Study Document
    Trial synopsis 1234.2_CO english
  • BI 11634 - Healthy
    Clinical Study Number 1234.7
    Study Indication Healthy
    Product BI 11634
    Generic Name BI 11634
    Lab Code
    Clinical Phase I
    Study Title

    An open, randomised, single-dose, four-way cross-over formulation finding study of the oral bioavailability of four prototype extended release formulations with 25 mg BI 11634, and intra-individual comparison to immediate-release tablets (25 mg) in healthy male volunteers

    Study Document
    Trial synopsis 1234.7 english
  • BI 1181181 - Healthy
    Clinical Study Number 1344.2
    Study Indication Healthy
    Product BI 1181181
    Generic Name BI 1181181
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BI 1181181 given orally q.d. for 10 days in young healthy male and elderly healthy male/female volunteers (randomized, double-blind, placebo controlled within dose groups, Phase I study)

    Study Document
    Trial statement 1344.2 english
  • BI 135585 - Healthy
    Clinical Study Number 1283.1
    Study Indication Healthy
    Product BI 135585
    Generic Name BI 135585
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of 10 mg to 1200 mg of BI 135585 XX administered as a solution to healthy male volunteers (trial part 1), followed by an open, randomised, single-dose, intra-individual bioavailability comparison of 200 mg BI 135585 XX as tabletand as solution (trial part 2)

    Study Document
    Trial synopsis 1283.1 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 135585 - Healthy
    Clinical Study Number 1283.3
    Study Indication Healthy
    Product BI 135585
    Generic Name BI 135585
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability and pharmacokinetics of 50 mg BI 135585 XX administered as tablet with and without food to healthy male volunteers (an open-label, randomised, single-dose, two-way crossover study)

    Study Document
    Trial synopsis 1283.3 english
  • BI 135585 - Healthy
    Clinical Study Number 1283.34
    Study Indication Healthy
    Product BI 135585
    Generic Name BI 135585
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and pharmacodynamics of BI 135585 XX administered as oral dose in healthy male volunteers (open-label, single-dose trial)

    Study Document
    Trial synopsis 1283.34 english
  • BI 137882 - Healthy
    Clinical Study Number 1306.1
    Study Indication Healthy
    Product BI 137882
    Generic Name BI 137882
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 137882 in healthy male volunteers (A randomised, single-blind, placebo-controlled Phase I study)

    Study Document
    Trial statement 1306.1_CO english
    Trial synopsis 1306.1_DS_DR english
  • BI 14332 - Healthy
    Clinical Study Number 1233.1
    Study Indication Healthy
    Product BI 14332
    Generic Name BI 14332
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (0.5 mg to 200 mg) of BI 14332 CL as powder in the bottle reconstituted with 0.1% tartaric acid administered to healthy male subjects. A randomised and placebo-controlled trial, double blinded within dose groups.

    Study Document
    Trial synopsis 1233.1 english
  • BI 14332 - Healthy
    Clinical Study Number 1233.2
    Study Indication Healthy
    Product BI 14332
    Generic Name BI 14332
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses (0.5, 2.5, 10 and 20 mg q.d. for 10 days) of BI 14332 CL as tablet in female and male patients with type 2 diabetes (randomised, double-blind, placebo-controlled within the dose groups), followed by a 4-week treatment part* (randomised, double-blind, placebo-controlled) of two doses (planned 5 and 20 mg) selected on the basis of tolerability and DPP-4 inhibition in the multiple rising dose (part* 4-week treatment part was not performed)

    Study Document
    Trial synopsis 1233.2_CO english
  • BI 14332 - Healthy
    Clinical Study Number 1233.3
    Study Indication Healthy
    Product BI 14332
    Generic Name BI 14332
    Lab Code
    Clinical Phase I
    Study Title

    Influence of a standardised high fat breakfast on the bioavailability of 10 mg BI 14332 CL taken as two tablets of 5 mg q.d. in healthy male volunteers (an open-label, randomised, single-dose, two-way crossover trial)

    Study Document
    Trial synopsis 1233.3_CO english
  • BI 144807 - Wet Macular Degeneration
    Clinical Study Number 1313.20
    Study Indication Wet Macular Degeneration
    Product BI 144807
    Generic Name BI 144807
    Lab Code
    Clinical Phase IIa
    Study Title

    A single arm open label study to evaluate the pharmacodynamics and safety of a 4 wk treatment with BI 144807 in patients with newly diagnosed wet age related macular degeneration (wAMD)

    Study Document
    Trial synopsis 1313.20_DR english
  • BI 224436 - Healthy
    Clinical Study Number 1277.1
    Study Indication Healthy
    Product BI 224436
    Generic Name BI 224436
    Lab Code
    Clinical Phase I
    Study Title

    Safety and pharmacokinetics of single rising oral doses of BI 224436 ZW at 6.2 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and1200 mg dose levels in healthy male volunteers (randomized, double-blind,placebo-controlled within dose groups). 

    Study Document
    Trial synopsis 1277.1_CO english
  • BI 2536 - Neoplasms
    Clinical Study Number 1216.1
    Study Indication Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I
    Study Title

    An open phase I single dose escalation study of BI 2536 BS administered intravenously in patients with advanced solid tumours with repeated administration in patients with clinical benefit

    Study Document
    Trial synopsis 1216.1_CO english
  • BI 2536 - Neoplasms
    Clinical Study Number 1216.2
    Study Indication Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I
    Study Title

    An open phase I repeated dose escalation study of BI 2536 BS administered intravenously in patients with advanced solid tumours with repeated administration in patients with clinical benefit

    Study Document
    Trial synopsis 1216.2_CO 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 - Pancreatic Neoplasms
    Clinical Study Number 1216.8
    Study Indication Pancreatic Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open-label dose-finding study of intravenous BI 2536 administered inrepeated 4-week cycles as repeated doses on Day 1 and Day 15 in combinationwith gemcitabine administered on Day 1, Day 8 and Day 15 in patients withlocally advanced or metastatic pancreatic cancer

    Study Document
    Trial synopsis 1216.8_CO english
  • BI 2536 - Lymphoma, Non-Hodgkin
    Clinical Study Number 1216.3
    Study Indication Lymphoma, Non-Hodgkin
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I
    Study Title

    An open Phase I single dose escalation study of BI 2536 administered intravenously in patients with refractory or relapsed non-Hodgkin’s lymphoma

    Study Document
    Trial synopsis 1216.3_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
  • BI 2536 - Pancreatic Neoplasms
    Clinical Study Number 1216.10
    Study Indication Pancreatic Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase II
    Study Title

    An open, randomised, clinical phase II trial in patients with unresectable advanced pancreatic cancer investigating the efficacy, safety, and pharmacokinetics of BI 2536 administered in repeated 3-week cycles as a single IV dose of 200 mg on Day 1 or as 60 mg doses on Days 1, 2, and 3

    Study Document
    Trial synopsis 1216.10 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
  • BI 2536 - Neoplasms
    Clinical Study Number 1216.18
    Study Indication Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase II
    Study Title

    Multicenter parallel phase II trial of BI 2536 administered as a 1 hour i.v. infusion every 3 weeks in defined cohorts of patients with various solid tumours. A new drug screening program of the EORTC network of core institutions (NOCI)

    Study Document
    Trial synopsis 1216.18_CO english
  • BI 2536 - Prostatic Neoplasms
    Clinical Study Number 1216.19
    Study Indication Prostatic Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase II
    Study Title

    A single arm phase II study to investigate the efficacy, safety and pharmacokinetics of a single dose of 200 mg of i.v. BI 2536, administered once every 3 weeks in patients with advanced metastatic hormone-refractory prostate cancer

    Study Document
    Trial synopsis 1216.19_CO english
  • BI 2536 - Leukemia, Myeloid, Acute
    Clinical Study Number 1216.20
    Study Indication Leukemia, Myeloid, Acute
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I/IIa
    Study Title

    An open, randomised clinical Phase I/IIa trial to investigate the maximum tolerated dose, efficacy, safety and pharmacokinetics of repeated three-week courses of a single dose i.v. BI 2536 on Day 1 in comparison to single doses i.v. BI 2536 on Days 1, 2 and 3 in patients over 60 years of age with refractory or relapsed acute myeloid leukaemia

    Study Document
    Trial synopsis 1216.20_CO english
  • BI 34021 - Healthy
    Clinical Study Number 1258.1
    Study Indication Healthy
    Product BI 34021
    Generic Name BI 34021
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of BI 34021 FU2 oral drinking solution in healthy male volunteers (dose range: 5 - 500 mg). A double-blind (within dose groups), randomised, placebo-controlled within dose groups,single-rising dose study, including re-dosing at 50 mg and 150 mg (food effect) and at 100 mg (two 50 mg tablets)

    Study Document
    Trial synopsis 1258.1 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
    Trial synopsis 1289.6 english
    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
    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
  • BI 411034 - Healthy
    Clinical Study Number 1308.1
    Study Indication Healthy
    Product BI 411034
    Generic Name n/a
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 411034 in healthy male volunteers (randomised, single-blind, placebo-controlled within dose groups, phase I study)

    Study Document
    Trial synopsis 1308.1_DR english
  • BI 416970 - Healthy
    Clinical Study Number 1345.1
    Study Indication Healthy
    Product BI 416970
    Generic Name BI 416970
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 416970 in healthy male volunteers in a partially randomised, single-blind, placebo-controlled trial

    Study Document
    Trial synopsis 1345.1_DR english
  • BI 44370 - Healthy
    Clinical Study Number 1246.1
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of BI 44370 TA oral drinking solution in healthy male volunteers (dose range: 5 - 800 mg). A double-blind (within dose groups), randomised, placebo-controlled within dose groups, single rising dose study, including re-dosing at 100 mg and 500 mg (solution) and at 200 mg (four 50 mg tablets).

    Study Document
    Trial synopsis 1246.1 english
  • BI 44370 - Healthy
    Clinical Study Number 1246.12
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising intravenous doses (10 to 50 mg) of BI 44370 BS solution in healthy male volunteers (randomised, single-blind, placebo-controlled within dosegroups, Phase I)

    Study Document
    Trial synopsis 1246.12 english
  • BI 44370 - Healthy
    Clinical Study Number 1246.14
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    A phase I trial to investigate the metabolism and pharmacokinetics of an open label single dose of 200 mg [14C]-BI 44370 BS administered as an oral solution in healthy male volunteers

    Study Document
    Trial synopsis 1246.14_CO english
  • BI 44370 - Healthy
    Clinical Study Number 1246.15
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising oral doses of BI 44370 TA tablets (100 mg, 200 mg and 300 mg three times every two hours on one day and q.d. for another 2 to 3 days) in healthy male and female volunteers, a randomised, double-blind, placebo-controlled within dose groups Phase I study

    Study Document
    Trial synopsis 1246.15 english
  • BI 44370 - Healthy
    Clinical Study Number 1246.2
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Relative oral bioavailability of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA tablets (100 mg as two 50 mg tablets) with and without a high fat meal in healthy male and female volunteers: a single dose, open-label, randomised, six-way cross-over trial

    Study Document
    Trial synopsis 1246.2 english
  • BI 44370 - Healthy
    Clinical Study Number 1246.3
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Effects of 100 mg and 500 mg BI 44370 TA orally applied as 50 mg tablets on the pharmacokinetics of 2 mg orally administered midazolam solution. An open-label, randomised, parallel group, fixed-sequence study with intra-individual comparison of midazolam pharmacokinetics with and without BI 44370 TA

    Study Document
    Trial synopsis 1246.3 english
  • BI 44370 - Migraine Disorders
    Clinical Study Number 1246.4
    Study Indication Migraine Disorders
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo- and active comparator-controlled, five parallel groups study to investigate the efficacy and safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) administered orally once during an acute migraine attack of moderate or severe intensity

    Study Document
    Trial synopsis 1246.4 english
  • BI 44370 - Migraine Disorders
    Clinical Study Number 1246.21
    Study Indication Migraine Disorders
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability following single oral administration of 200 mg of BI 44370 during and between migraine attacks in male and female migraine patients. An open-label, fixed-sequence, two-period study with intraindividual comparison

    Study Document
    Trial synopsis 1246.21 english
  • BI 44847 - Healthy
    Clinical Study Number 1224.1
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (2.5 mg to 1200 mg) of BI 44847 as powder in the bottle reconstituted with 0.2% natrosol solution administered to healthy male subjects. A randomised, placebo-controlled (within dose groups) and double-blinded trial

    Study Document
    Trial synopsis 1224.1 english
  • BI 44847 - Healthy
    Clinical Study Number 1224.11
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (50 mg to 800 mg) of BI 44847 as tablet(s) administered to healthy male subjects. A randomised, placebo-controlled (within dose groups) and double-blinded trial.

    Study Document
    Trial synopsis 1224.11_CO english
  • BI 44847 - Healthy
    Clinical Study Number 1224.2
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Relative oral bioavailability of 400 mg BI 44847 as suspension compared to 400 mg BI 44847 as tablet and the influence of food (standardised high fat breakfast) on the tablet in a single dose, open label, randomised three-way crossover trial and relative oral bioavailability of 40 mg BI 44847 as solution compared to 40 mg BI 44847 as tablet in healthy male volunteers in a single dose, open-label, randomised two-way crossover trial.

    Study Document
    Trial synopsis 1224.2 english
  • BI 44847 - Healthy
    Clinical Study Number 1224.22
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Evaluation of relative bioavailability of BI 44847 in different ethnic groups (subjects of white, Asian, and African origin), and evaluation of effect of diet and a carbose coadministration on bioavailability following oral administration of 200 mg BI 44847 in healthy male volunteers. An open-label, single-dose, parallel-group, phase I study (group 1 with additional crossover aspects)

    Study Document
    Trial synopsis 1224.22_CO 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
  • 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