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 ® - Atrial Fibrillation
    Clinical Study Number 1160.26
    Study Indication Atrial Fibrillation
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

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

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

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

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

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

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

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

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

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

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

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

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

    Comparative effectiveness of oral anticoagulants: A cohort study

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Study Document Trial synopsis 1160-0288 english

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