Twice-Daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-Term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism.

Trial Profile

Twice-Daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-Term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism.

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2014

At a glance

  • Drugs Dabigatran etexilate (Primary)
  • Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RE-SONATE; RE-VOLUTION
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 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.
    • 24 Jun 2013 Data from this trial and three others in the RE-VOLUTION programme supported a submission of an application to the European Medicines Agency (EMA), according to a Boehringer Ingelheim media release.
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