Value through Innovation27 July 2016

Clinical Study Results

  • 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 ® - 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 ® - 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 ® - 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

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