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 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.

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Trial Profile

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 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Feb 2017

At a glance

  • Drugs Dabigatran etexilate (Primary) ; Warfarin
  • Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism
  • Focus Registrational; Therapeutic Use
  • Acronyms RE-MEDY; RE-VOLUTION
  • Sponsors Boehringer Ingelheim Pharmaceuticals

    • Most Recent Events

    • 06 Dec 2016 Results (n=1280) of a pooled post-hoc analysis of two RE- COVER and RE-MEDY trials presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 02 Oct 2013 Pooled analysis of RE-LY, RE-COVER I & II, RE-MEDY and RE-SONATE published in Circulation, according to a Boehringer Ingelheim Pharmaceuticals media release.
    • 28 Aug 2013 Data from global phase III studies, including this trial, supported an sNDA to the US FDA, according to a Boehringer Ingelheim media release.
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