Value through Innovation27 July 2016

Clinical Study Results

  • PRAXBIND ® - Healthy
    Clinical Study Number 1321.1
    Study Indication Healthy
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase I
    Study Title

    Randomised, double-blind, placebo-controlled Phase I study in healthy male volunteers to investigate safety, tolerability and pharmacokinetics of single rising doses of BI 655075 (part 1) and to explore the dose of BI 655075 effective to reverse dabigatran anticoagulant activity (part 2)

    Study Document Trial synopsis 1321.1 english
  • PRAXBIND ® - Renal Insufficiency
    Clinical Study Number 1321.2
    Study Indication Renal Insufficiency
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase I
    Study Title

    Randomised, double-blind, placebo-controlled, two-way cross-over Phase Ib study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655075 and to establish the efficacy of BI 655075 in reversal of dabigatran anticoagulant activity in volunteers

    Study Document Trial synopsis 1321.2 english
  • PRAXBIND ® - Healthy
    Clinical Study Number 1321.5
    Study Indication Healthy
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase I
    Study Title

    Randomised, double-blind within dose groups, placebo-controlled Phase I trial inhealthy Japanese male volunteers to investigate safety, tolerability andpharmacokinetics of different doses of BI 655075 (part 1) and to explore theeffective dose of BI 655075 to reverse dabigatran anticoagulant activity (part 2)

    Study Document Trial synopsis 1321.5 english
  • PRAXBIND ® - Hemorrhage
    Clinical Study Number 1321.3
    Study Indication Hemorrhage
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0 g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. RE-VERSE-AD (A study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) trial

    Study Document Trial synopsis 1321.3 english Lay summary 1321.3 english
  • PRAXBIND ® - Hemorrhage
    Clinical Study Number 1321.14
    Study Indication Hemorrhage
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase III/IV
    Study Title

    A compassionate use program of idarucizumab for reversal of the anticoagulant effects of dabigatran in Japanese patients who have uncontrolled bleeding or require emergency surgery or procedures

    Study Document Trial synopsis 1321.14 english
  • PRAXBIND ® - Healthy
    Clinical Study Number 1321.6
    Study Indication Healthy
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase I
    Study Title

    Open label Phase I trial in healthy Chinese male and female volunteers to investigate pharmacokinetics and pharmacodynamics of idarucizumab to reverse dabigatran anticoagulant activity

    Study Document Trial synopsis 1321.6 english
  • PRAXBIND ® - Hemorrhage
    Clinical Study Number 1321-0022
    Study Indication Hemorrhage
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase IV
    Study Title

    Medical Need of Non-vitamin K Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Emergency Surgery, Major Bleeding due to Trauma and Fracture, using Large Scale Claims Database

    Study Document Trial synopsis 1321-0022 english

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