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Clinical trial

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 Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II)

NCT00657150 is registered in ClinicalTrials.gov with Boehringer Ingelheim as lead sponsor.

NCT NCT00657150
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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 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 Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II)
Lead sponsor
Boehringer Ingelheim
Phase
Phase 3
Overall status
Completed
Start date
March 31, 2008
Completion date
Not reported
Enrollment
2,055 (actual)
Sites
108

Conditions

As the registry lists them; a condition with its own page is linked.

venous thromboembolism