Clinical trial
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 (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)
NCT00168818 is registered in ClinicalTrials.gov with Boehringer Ingelheim as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- 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 (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)
- Lead sponsor
- Boehringer Ingelheim
- Phase
- Phase 3
- Overall status
- Completed
- Start date
- November 30, 2004
- Completion date
- Not reported
- Enrollment
- 3,494 (actual)
- Sites
- 116
Conditions
As the registry lists them; a condition with its own page is linked.
arthroplasty, replacement, hip, thromboembolism