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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Feb 2017

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At a glance

  • Drugs Idarucizumab (Primary)
  • Indications Blood coagulation disorders
  • Focus Adverse reactions; Pharmacodynamics; Proof of concept
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 23 Feb 2017 Results of pooled analysis (NCT01688830, NCT01955720 and NCT02028780) published in the British Journal of Clinical Pharmacology
    • 17 Jun 2016 Results published in the Clinical Pharmacokinetics
    • 03 Mar 2015 Based on phase I data and interim REVERSE-AD results, Boehringer Ingelheim submitted idarucizumab for approval to the EMA, FDA and Health Canada, for patients who require reversal of the anticoagulant effect of dabigatran, according to a media release.
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