Value through Innovation27 July 2016

Clinical Study Results

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

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

    Study Document Trial synopsis 1160.128_DR english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.194
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of dabigatran after administration of different dosage forms of multiple doses of 150 mg dabigatran etexilate (hard capsule, granules resolved in reconstitution solution, pellets on food) in healthy male volunteers (an open-label, randomised, multiple-dose, three way crossover study

    Study Document Trial synopsis 1160.194_DR english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.63
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    Twice-daily oral direct thrombin inhibitor dabigatran etexilate in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism RESONATE

    Study Document Trial synopsis 1160.63_DR english
  • PRADAXA ® - Thromboembolism
    Clinical Study Number 1160.103
    Study Indication Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

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

    Study Document Trial Statement 1160.103_DR english Trial synopsis 1160.103_DR english
  • PRADAXA ® - Arthroplasty, Replacement, Knee
    Clinical Study Number 1160.25
    Study Indication Arthroplasty, Replacement, Knee
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

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

    Study Document Trial synopsis 1160.25_DR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.26
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

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

    Study Document Trial synopsis 1160.26_DR english
  • PRADAXA ® - Thromboembolism
    Clinical Study Number 1160.48
    Study Indication Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with half dose (i.e. 75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 28-35 days, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery. RE-NOVATE (Extended thromboembolism prevention after hip surgery)

    Study Document Trial synopsis 1160.48_DR english
  • PRADAXA ® - Arthroplasty, Replacement, Knee
    Clinical Study Number 1160.50
    Study Indication Arthroplasty, Replacement, Knee
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

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

    Study Document Trial synopsis 1160.50_DS_CO english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.64
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of orally administered 220 mg dabigatran etexilate capsules (110 mg administered on the day of surgery followed by 220 mg once daily) compared to subcutaneous 40 mg enoxaparin once daily for 28-35 days in prevention of venous thromboembolism in patients following primary elective total hip arthroplasty (RE-NOVATE II)

    Study Document Trial synopsis 1160.64_DR english
  • PRADAXA ® - Coronary Disease
    Clinical Study Number 1160.67
    Study Indication Coronary Disease
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

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

    Study Document Trial synopsis 1160.67_DR english
  • PRADAXA ® - Thromboembolism
    Clinical Study Number 1160.47
    Study Indication Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, multicenter, double-blind, parallel-group, active controlled study to evaluate the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0 to 3.0) for the secondary prevention of venous thromboembolism. RE-MEDY

    Study Document Trial synopsis 1160.47_DR english
  • PRADAXA ® - Cardiac Catheterization
    Clinical Study Number 1160.73
    Study Indication Cardiac Catheterization
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

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

    Study Document Trial synopsis 1160.73 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.20
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

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

    Study Document Trial synopsis 1160.20_DS_CO english
  • PRADAXA ® - Arthroplasty, Replacement, Knee
    Clinical Study Number 1160.24
    Study Indication Arthroplasty, Replacement, Knee
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

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

    Study Document Trial synopsis 1160.24_DS_CO english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.42
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

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

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

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

    Study Document Trial synopsis 1160.49_DS_CO english
  • PRADAXA ® - Thromboembolism
    Clinical Study Number 1160.53
    Study Indication Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind, parallel-group study of the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism, following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. RE-COVER

    Study Document Trial synopsis 1160.53_DR english
  • PRADAXA ® - Thromboembolism
    Clinical Study Number 1160.19
    Study Indication Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of different doses (50 mg b.i.d., 150 mg b.i.d., 225 mg b.i.d. and 300 mg q.d.) of BIBR 1048 administered orally (capsules), compared to Enoxaparin 40 mg once a day subcutaneous, in prevention of venous thrombo-embolism in patients with primary elective total hip or knee replacement surgery. BISTRO - 2 Study (Boehringer Ingelheim Study in ThROmbosis)

    Study Document Trial synopsis 1160.19_DS_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.117
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of two different capsule types of 150 mg dabigatran etexilate made from two different drug product batches, following oral administration in healthy male and female volunteers (open-label, randomised, single dose, replicate design in a two treatments, four periods crossover phase I study)

    Study Document Trial synopsis 1160.117 english
  • PRADAXA ® - Thromboembolism
    Clinical Study Number 1160.46
    Study Indication Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III a
    Study Title

    A phase III, randomised, double blind, parallel-group study of the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism, following initial treatment for at least 5 days with a parenteral anticoagulant approved for this indication. RE-COVER II

    Study Document Trial synopsis 1160.46_DR english
  • PRADAXA ® - Cardiovascular Diseases
    Clinical Study Number 1160.121
    Study Indication Cardiovascular Diseases
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

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

    Study Document Trial synopsis 1160.121 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.112
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single dose of 150 mg dabigatran etexilate (capsule) when administered alone or in combination with a single dose of 400 mg Dronedarone (tablet) or in combination with 400 mg bid Dronedarone (tablet) at steady state in healthy male and female volunteers (an open label, randomised, four-sequence, two period cross-over, Phase I study)

    Study Document Trial synopsis 1160.112 english
  • PRADAXA ® - Arthroplasty, Replacement
    Clinical Study Number 1160.85
    Study Indication Arthroplasty, Replacement
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

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

    Study Document Trial synopsis 1160.85_DR english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.88
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

    Open-label safety and tolerability study of dabigatran etexilate given for 3 days at the end of standard anticoagulant therapy in children aged 12 years to less than 18 years

    Study Document Trial synopsis 1160.88_DS_CO english
  • PRADAXA ® - Thromboembolism
    Clinical Study Number 1160.138
    Study Indication Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

    Evaluation of the long term safety of the use of dabigatran etexilate in patients with a bileaflet mechanical heart valve

    Study Document Trial synopsis 1160.138_DS_DR english Trial statement 1160.138_DR english
  • PRADAXA ® - Heart Valve Diseases
    Clinical Study Number 1160.113
    Study Indication Heart Valve Diseases
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase II
    Study Title

    A Randomised, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGatran etexilate in patients after heart valve replacemeNt (RE-ALIGN)

    Study Document Trial statement 1160.113_DR english Trial synopsis 1160.113_DR english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.141
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of pharmacodynamic effects of dabigatran and ticagrelor (Part 1   and 2, open, non-randomised, 2 parallel groups) and assessment of ticagrelor interaction potential with dabigatran (Part 3, open, randomised, two-period cross-over) in healthy male subjects

    Study Document Trial synopsis 1160.141_DR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.71
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIIb
    Study Title

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

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

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

    Study Document Trial synopsis 1160.114_DR english
  • PRADAXA ® - Arthroplasty, Replacement, Knee
    Clinical Study Number 1160.86
    Study Indication Arthroplasty, Replacement, Knee
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

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

    Study Document Trial synopsis 1160.86_DR english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.142
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of drug-drug interaction of dabigatran and ticagrelor under steadystate conditions in healthy male subjects

    Study Document Trial synopsis 1160.142_DR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.157
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Comparative effectiveness of oral anticoagulants: A cohort study

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

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

    Study Document Trial synopsis 1160.170_CO english
  • PRADAXA ® - Renal Insufficiency, Chronic
    Clinical Study Number 1160.166
    Study Indication Renal Insufficiency, Chronic
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase Ib
    Study Title

    An exploratory study to investigate the pharmacokinetics and effects of DABIgatran etexilate in patients with stable severe RENAL disease: DabiRenal

    Study Document Trial synopsis 1160.166 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.1
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacodynamics, safety and pharmacokinetics after single oral administration of 10, 30, 100, 200 and 400 mg BIBR 1048 MS as drinking solution in healthy subjects. An open study, placebo randomised double blind at each dose level.

    Study Document Trial synopsis 1160.1 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.10
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of BIBR 953 ZW after 150 mg of BIBR 1048 (oral pro-drug of BIBR 953) administered as capsule twice daily over seven days with or without Pantoprazole co-treatment to healthy male and female elderly subjects

    Study Document Trial synopsis 1160.10_CO english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.11
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

    Multicenter, open-label, ascending dose study of BIBR 1048 in the prevention of venous thromboembolism in patients undergoing primary elective total hip replacement surgery. Bistro I (Boehringer Ingelheim Study in ThROmbosis).

    Study Document Trial synopsis 1160.11 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.14
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of BIBR 953 ZW after multiple oral doses of 50 and 200 mg BIBR 1048 MS film-coated tablet administered BID for 3 days of 200 mg BIBR 1048 MS with and without pre-treatment with Pantoprazole to healthy volunteer subjects. Two groups, 2-way crossover, randomised, open trial.

    Study Document Trial synopsis 1160.14 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.15
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of BIBR 953 ZW after single oral doses of 12.5, 25, 50 or 100 mg BIBR 1048 MS film-coated tablet with and without pre-treatment with pantoprazole to healthy subjects. Four groups, 2-way crossover, randomised, open trial.

    Study Document Trial synopsis 1160.15 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.16
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of BIBR 953 ZW after single oral doses of 12.5, 50 or 200 mg BIBR 1048 MS film-coated tablet over 2 days with and without coadministration of ranitidine to healthy subjects. Three groups, 2-way crossover, randomised, open trial.

    Study Document Trial synopsis 1160.16_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.17
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of BIBR 953 ZW after single oral doses of two different 50 mg capsules of BIBR 1048 MS with and without coadministration of Pantoprazole in healthy subjects relative to solution. Two groups, 3-way crossover, randomised, open trial.

    Study Document Trial synopsis 1160.17 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.2
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacodynamics, and pharmacokinetics after multiple oral doses of 50, 100, 200, and 400 mg BIBR 1048 MS solution administered TID for 7 days to healthy volunteer subjects. An open study, placebo-controlled randomized double blind at each dose level.

    Study Document Trial synopsis 1160.2 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.28
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacokinetics and pharmacodynamics after single rising oral doses of 50, 150 and 350 mg BIBR 1048 MS as capsules in healthy subjects of Japanese and Caucasian origin. Double-blind at each dose level, placebo-controlled, randomised study

    Study Document Trial synopsis 1160.28_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.29
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacokinetics and pharmacodynamics after single (150 mg, 220 mg and 300 mg) and multiple (150 mg and 220 mg q.d. and 150 mg b.i.d.) rising oral doses of BIBR 1048 MS/capsules in healthy male subjects of Japanese and Caucasian origin (Open label study)

    Study Document Trial synopsis 1160.29_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.3
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 200 mg film coated tablets of BIBR 1048 MS with or without food compared to 200 mg solution of BIBR 1048 MS given as single oral administrations to healthy subjects: a 3-way cross-over, open, partly randomised study.

    Study Document Trial synopsis 1160.3 english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.30
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

    Multicenter, open-label, ascending dose study of BIBR 1048 in prevention of venous thromboembolism in patients undergoing primary elective total hip replacement surgery

    Study Document Trial synopsis 1160.30 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.31
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of BIBR 953 ZW after 50 mg of BIBR 1048 MS (oral prodrug of BIBR 953) in 4 experimental formulations relative to drinking solution of BIBR 1048 MS, each treatment given bid over 3 days, in healthy subjects. Intraindividual comparison (5-way crossover), randomised, open. For each of the 5 treatments, investigation of 2 conditions: with and without Pantoprazole (intraindividual, open comparison).

    Study Document Trial synopsis 1160.31_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.32
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of BIBR 953 ZW after 50 mg of BIBR 1048 MS (oral prodrug of BIBR 953) in 4 experimental formulations relative to drinking solution of BIBR 1048 MS, each treatment given bid over 3 days, in healthy subjects. Intraindividual comparison (5-way crossover), randomised, open. For each of the 5 treatments, investigation of 2 conditions: with and without Pantoprazole (intraindividual, open comparison).

    Study Document Trial synopsis 1160.32 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.33
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of BIBR 953 ZW after 50 mg of BIBR 1048 MS (oral prodrug of BIBR 953) in 2 experimental formulations relative to drinking solution of BIBR 1048 MS, each treatment given bid over 3 days in healthy subjects. Intraindividual comparison (3-way crossover) with and without Pantoprazole, randomised, open.

    Study Document Trial synopsis 1160.33 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.34
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase Ia
    Study Title

    Bioavailability of BIBR 953 ZW after 150 mg of BIBR 1048 (oral pro-drug of BIBR 953) administered as capsule with and without coadministration of Pantoprazole as well as under the influence of food in healthy subjects. A three-way crossover, randomised, open trial.

    Study Document Trial synopsis 1160.34 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.40
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of BIBR 953 ZW after 150 mg of BIBR 1048 (oral prodrug of BIBR 953 ZW) administered as HPMC capsule relative to a gelatine capsule, and bioavailability of the HPMC capsule under the influence of food in healthy subjects. A three-way crossover, randomised, open trial

    Study Document Trial synopsis 1160.40 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.5
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Tolerability of single rising doses of 0.1 mg, 1 mg, and 5 mg BIBR 953 ZW IV (placebo-controlled in each dose group; substudy 1) and absolute and relative bioavailability of 100mg BIBR 1048 tablet and of solution and of 1 mg or 5mg BIBR 953 ZW IV (randomised, three-way crossover; substudy 2).

    Study Document Trial synopsis 1160.5 english
  • PRADAXA ® - Hepatic Insufficiency
    Clinical Study Number 1160.51
    Study Indication Hepatic Insufficiency
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, pharmacodynamics, safety and tolerability of 150 mg dabigatran etexilate p.o. in patients with moderate hepatic impairment compared to subjects with normal hepatic function in a monocentric, open, parallel-group design

    Study Document Trial synopsis 1160.51_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.52
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of BIBR 953 ZW after 150 mg of BIBR 1048 (oral pro-drug of BIBR 953 ZW) administered as HPMC polymorph II capsule relative to 150 mg HPMC polymorph I capsule in healthy subjects. A two-way crossover, randomised, open trial

    Study Document Trial synopsis 1160.52_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.54
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of electrophysiological effects of 150 mg and 600 mg of dabigatran etexilate as single dose on the QT interval in healthy female and male subjects. A randomised, placebo controlled, double-blind three-way crossover study with an open label positive control (moxifloxacin)

    Study Document Trial synopsis 1160.54 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.55
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase 1160.55
    Study Title

    Safety, pharmacokinetics and pharmacodynamics after multiple oral doses of BIBR 1048 MS capsule (150 mg b.i.d., 7 days) in healthy Japanese male subjects (Open label study)

    Study Document Trial synopsis 1160.55_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.56
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of two different drug product batches of 150 mg of dabigatran etexilate following oral administration in healthy male and female volunteers (double blind, randomised, single-dose, replicate design in a two-treatments, four periods crossover study)

    Study Document Trial synopsis 1160.56_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.57
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative Bioavailability of Dabigatran and Amiodarone after Multiple Oral Administrations of 150 mg Dabigatran Etexilate b.i.d. with or without 600 mg Amiodarone as Single Dose in Healthy Male and Female Volunteers (an Open-Label, Multiple-Dose, Group-comparison Study)

    Study Document Trial synopsis 1160.57_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.58
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative Bioavailability of dabigatran and atorvastatin after 150 mg BID dabigatran etexilate and atorvastatin at 80 mg QD alone or following concomitant multiple oral administrations in healthy male and female volunteers (an open-label, randomised, multiple-dose, three-way crossover study)

    Study Document Trial synopsis 1160.58_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.59
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of dabigatran and digoxin after 150 mg b.i.d dabigatran etexilate and digoxin at 0.25 mg q.d. alone or following concomitant multiple oral administrations in healthy male and female volunteers (an open label, randomised, multiple-dose, three-way crossover study)

    Study Document Trial synopsis 1160.59_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.6
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Metabolism and Pharmacokinetics of [14C]-BIBR 953 ZW after Administration of Single Doses of 5 mg [14C]-BIBR 953 ZW Intravenously or 200 mg [14C]-BIBR 1048 Oral Solution in a Group Comparison Design in 12 Healthy Male Volunteers.

    Study Document Trial synopsis 1160.6_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.60
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacodynamics and pharmacokinetics after single oral administration of 600 mg, 750 mg and 900 mg dabigatran etexilate as capsule in healthy subjects. A randomised, placebo-controlled study, double blind at each dose level

    Study Document Trial synopsis 1160.60 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.61
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety, and pharmacodynamics after multiple oral doses of dabigatran etexilate capsule (110 mg and 150 mg b.i.d., 7 days) in healthy Japanese and Caucasian male subjects (Open label study)

    Study Document Trial synopsis 1160.61_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.66
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of two different polymorphs of 150 mg dabigatran etexilate following oral administration in healthy male and female volunteers (double-blind, randomised, single dose, replicate design in a two treatments, four periods crossover phase I study)

    Study Document Trial synopsis 1160.66_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.68
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 2x5 mg of IVAX warfarin /formulation tablet compared to10 mg of Coumadin /formulation tablet following oral administration in healthy male volunteers (an open-label, randomised, single-dose, two-treatment, two-sequence crossover study) under fasted conditions

    Study Document Trial synopsis 1160.68_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.7
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative Bioavailability of Dabigatran and Diclofenac after 150 mg b.i.d. Dabigatran etexilate and Diclofenac at 50 mg Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers (an Open Label, Randomised, Multiple-Dose, Three-way Crossover Study)

    Study Document Trial synopsis 1160.7_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.70
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of two different generations of drug product of 150 mg dabigatran etexilate following oral administration in healthy male and female volunteers (double-blind, randomised, single dose, replicate design in a two treatments, four periods crossover phase I study)

    Study Document Trial synopsis 1160.70_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.74
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of 150 mg dabigatran etexilate with or without oral administration of verapamil in two different dosages (240 and 480 mg daily) and administered at different time points relative to dabigatran etexilate dosing in healthy male and female volunteers (open-label, fixed-sequence phase I study), and relative bioavailability of single oral doses of 150 mg dabigatran etexilate given with or without single oral doses of 120 mg verapamil immediate release or 240 mg verapamil extended release (open-label, randomised, five-way crossover phase I study)

    Study Document Trial synopsis 1160.74_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.75
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    A two-part study to determine the relative bioavailability of dabigatran etexilate 150 mg bid (capsules) with and without 600 mg quinidine sulfate tablets (Part 1) and to measure the effect of quinidine as a probe inhibitor of P-glycoprotein on the absorption of fexofenadine, a probe substrate of P-glycoprotein (Part 2) in healthy male and female volunteers (an open label, randomised, two times two-way crossover study)

    Study Document Trial synopsis 1160.75_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.78
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability and pharmacodynamics of dabigatran after a single dose of 220 mg dabigatran etexilate and after 40 mg enoxaparin s.c. for 3 days followed by a single dose of 220 mg dabigatran etexilate in healthy male and female volunteers (an open-label, randomised, single and multiple dose, two-way crossover phase I study)

    Study Document Trial synopsis 1160.78_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.81
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics study after single and multiple oral doses of BIBR 1048 MS capsule (110mg,150 mg b.i.d., 7 days) in healthy Chinese male subjects (Open label study)

    Study Document Trial synopsis 1160.81 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.82
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of dabigatran after single oral administration of 150 mg dabigatran etexilate (capsule) with or without multiple oral administration of 500 mg clarithromycin (tablet) bid in healthy male and female volunteers (an open label, fixed sequence, clinical phase I study)

    Study Document Trial synopsis 1160.82 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.83
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Randomised, open label, 3-way cross over phase I study to investigate the impact of concomitant use of multiple doses of clopidogrel (75 mg qd after a loading dose of 300 mg) with multiple doses of dabigatran etexilate (150 mg bid) on the pharmacokinetic and pharmacodynamic parameters, and additionally the impact of single oral doses of 300 mg and 600 mg of clopidogrel administered under steady state conditions of dabigatran of 75 mg and 150 mg in healthy male subjects

    Study Document Trial synopsis 1160.83_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.87
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of dabigatran after administration of different application forms of a single oral dose of 150 mg dabigatran etexilate (capsule, powder for reconstitution into solution, pellets on food) in healthy male and female volunteers (an open-label, randomised, three-way crossover, clinical phase I study)

    Study Document Trial synopsis 1160.87_DS english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.90
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    A two-way crossover study to evaluate the safety and pharmacokinetics ofquinidine sulfate alone (200 mg orally q2h to a maximum of 1,000 mg),dabigatran etexilate alone (150 mg BID for three days), and the co-administrationof dabigatran etexilate (150 mg BID) with quinidine sulfate (200 mg q2h)

    Study Document Trial synopsis 1160.90_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.100
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase Ia
    Study Title

    Relative bioavailability of single doses of 150 mg dabigatran etexilate (capsule) when administered alone, after seven days of sosing with 600 mg rifampicin (tablet), and seven days and fourteen days after last administration of rifampicin in healthy male and female volunteers (an open label, fixed sequence, Phase I study)

    Study Document Trial synopsis 1160.100_CO english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.101
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase Ia
    Study Title

    Relative bioavailability of single doses of 150 mg dabigatran etexilate (capsule) when administered alone or in combination with a single dose of 400 mg ketoconazole (tablet) or in combination with 400 mg q.d. ketoconazole (tablet) at steady state in healthy male and female volunteers (an open label, fixed sequence, Phase I study)

    Study Document Trial synopsis 1160.101 english
  • PRADAXA ® - Arthroplasty, Replacement
    Clinical Study Number 1160.84
    Study Indication Arthroplasty, Replacement
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

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

    Study Document Trial synopsis 1160.84_DR english
  • PRADAXA ® - Renal Insufficiency
    Clinical Study Number 1160.23
    Study Indication Renal Insufficiency
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, pharmacodynamics, safety and tolerability of 150 mg dabigatran etexilate p.o. in patients with different degrees of renal impairment in comparison to subjects with normal renal function in a monocentric, open, parallel-group trial

    Study Document Trial synopsis 1160.23_CO english
  • PRADAXA ® - Arthroplasty, Replacement
    Clinical Study Number 1160.118
    Study Indication Arthroplasty, Replacement
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

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

    Study Document Trial synopsis 1160.118_DR english Trial statement 1160.118_DR english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.183
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

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

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

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

    Study Document Trial synopsis 1160.149_DR english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.105
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

    Open-label, single dose, tolerability, Pharmacokinetic/Pharmacodynamics and safety study of dabigatran etexilate given at the end of standard anticoagulant therapy in children aged less than 1 year old

    Study Document Trial synopsis 1160.105_DR english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.89
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

    Single dose open-label PK/PD, safety and tolerability study of dabigatran etexilate mesilate given at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years followed by 1 year to less than 2 years

    Study Document Trial synopsis 1160.89_CO english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.173
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

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

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

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

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

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

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

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

    Study Document Trial synopsis 1160.263_PR english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.246
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of dabigatran after single oral administration of five different tablet formulations of dabigatran etexilate compared to commercial capsule formulation in healthy male subjects (an open-label, randomised, single-dose, six-period, five-sequence crossover study)

    Study Document Trial synopsis 1160.246 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.144
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

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

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

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

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

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

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

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

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

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

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

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

    Study Document Trial synopsis 1160.200 english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.102
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Cohort study in prevention of venous thromboembolic events after orthopaedic surgery in patients treated with Pradaxa®

    Study Document Trial synopsis 1160.102 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.247
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

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

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

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

    Study Document Trial synopsis 1160.186 english Lay summary 1160.186 english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160-0271
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of tablet formulation of dabigatran etexilate compared to commercial capsule formulation following oral administration in healthy male subjects (an open-label, randomised, single-dose, replicate design in a two-treatment, four-period, two-sequence crossover study)

    Study Document Trial synopsis 1160-0271 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.219
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

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

    Study Document Trial synopsis 1160.219_PR english
  • PRADAXA ® - Healthy
    Clinical Study Number 1160.270
    Study Indication Healthy
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of tablet formulation of dabigatran etexilate with and without co-administration of rabeprazole in healthy male subjects (an open-label, single-oraldose, two-period, single-arm study)

    Study Document Trial synopsis 1160.270 english
  • PRADAXA ® - Atrial Fibrillation
    Clinical Study Number 1160.249
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

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

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

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

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

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

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

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

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

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

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

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

    Study Document Trial synopsis 1160.261 english

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