A Phase III, Randomised, Double Blind, Parallel-Group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.

Trial Profile

A Phase III, Randomised, Double Blind, Parallel-Group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2017

At a glance

  • Drugs Dabigatran etexilate (Primary) ; Warfarin
  • Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism; Venous thromboembolism
  • Focus Registrational; Therapeutic Use
  • Acronyms RE-COVER-II; RE-VOLUTION
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 04 Oct 2017 Results (n=5107) of post hoc subgroup analyses of pooled data from the RE-COVER-I and RE-COVER-II trials assessing effects of old age and renal impairment on efficacy and safety of dabigatran versus warfarin published in the Thrombosis and Haemostasis
    • 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
    • 14 Jul 2016 Results of a pooled analysis of data from RE-COVER and RE-COVER II trials (n=5107) published in the Thrombosis and Haemostasis.
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