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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Apr 2022

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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

  • 01 Sep 2020 Results of meta analysis determining the efficacy and safety of NOACs vs. VKAs in patients with different age, sex and renal function for the treatment of VTE presented at the ESC Congress 2020 - Annual Congress of the European Society of Cardiology
  • 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

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