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.
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History