Value through Innovation27 July 2016

Clinical Study Results

  • 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 ® - 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 ® - 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 ® - 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 ® - 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 ® - 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

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