A Phase III Randomised, Parallel Group, Double-Blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (i.e. 75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery: RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery).

Trial Profile

A Phase III Randomised, Parallel Group, Double-Blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (i.e. 75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery: RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery).

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; Venous thromboembolism
  • Focus Registrational; Therapeutic Use
  • Acronyms RE-NOVATE; 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 70033030).
    • 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 II trial. (see CT profile 70033030)
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