A Phase III Randomised, Parallel Group, Double-Blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Compared to Subcutaneous 40 mg Enoxaparin [enoxaparin sodium] Once daily Daily for 28-35 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II).

Trial Profile

A Phase III Randomised, Parallel Group, Double-Blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Compared to Subcutaneous 40 mg Enoxaparin [enoxaparin sodium] Once daily Daily for 28-35 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II).

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Nov 2015

At a glance

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

    • 23 Nov 2015 Results published in a Boehringer Ingelheim media release.
    • 23 Nov 2015 According to a Boehringer Ingelheim Pharmaceuticals media release, the US FDA has approved dabigatran etexilate mesylate (Pradaxa) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery. The approval was based on this results of this an another phase III trial (see CT profile 70010368).
    • 06 Apr 2015 According to a Boehringer Ingelheim Pharmaceuticals media release, the company has filed a supplementary NDA to the US-FDA for dabigatran etexilate mesylate (Pradaxa) for the prophylaxis of deep venous thrombosis and pulmonary embolism based on the results of this and and RE-NOVATE trial. (see CT profile 70010368)
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