A Phase III, Randomized, Parallel-group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 Followed by 150 mg Day 2-completion, and 110 mg Day 1 Followed by 220 mg Day 2-completion) of Dabigatran Etexilate Administered Orally (Capsules), Compared to Enoxaparin 30 mg Twice a Day Subcutaneous for 12 - 15 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery.

Trial Profile

A Phase III, Randomized, Parallel-group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 Followed by 150 mg Day 2-completion, and 110 mg Day 1 Followed by 220 mg Day 2-completion) of Dabigatran Etexilate Administered Orally (Capsules), Compared to Enoxaparin 30 mg Twice a Day Subcutaneous for 12 - 15 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery.

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2014

At a glance

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

    • 13 Dec 2011 Results from a pooled analysis presented at the 53rd Annual Meeting and Exposition of the American Society of Hematology.
    • 16 Nov 2011 Results from a pooled analysis presented at the 84th Annual Scientific Sessions of the American Heart Association.
    • 16 Dec 2010 Actual end date changed from 1 Nov 2006 to 1 Jun 2006 as reported by ClinicalTrials.gov.
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