RE-COVER II, 1160.46, Treatment for Acute Venous Thromboembolism (VTE)

• Research type

  Research Study

• Full title

  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 for at least 5 days with a parenteral anticoagulant approved for this indication. RE-COVER II

• IRAS ID

  9351

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2007-002631-86

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT00680186

• Research summary

  This is a 6 month study to assess the effect of Dabigatran etexilate compared to warfarin in patients with acute symptomatic venous thromboembolism (VTE). VTE events include deep vein thrombosis (DVT) and pulmonary embolism (PE). It is a double blind parallel arm study performed with patients for whom at least 6 months of anticoagulant therapy is considered appropriate by the Investigator.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  08/H0605/152

• Date of REC Opinion

  17 Nov 2008

• REC opinion

  Favourable Opinion