Value through Innovation27 July 2016

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Clinical Study Results

  • 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 ® - 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 ® - 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