NCT00168818

Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,494 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

Conditions

• Thromboembolism
• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DRUG	dabigatran etexilate	daily dose 150 mg once daily, half a dose on the day of surgery
DRUG	dabigatran etexilate	daily dose 150 mg once daily, half a dose on the day of surgery
DRUG	enoxaparin	40 mg once daily

Timeline

• Start date: 2004-11-01
• Primary completion: 2006-07-01
• First posted: 2005-09-15
• Last updated: 2014-05-19
• Results posted: 2010-12-20

Locations

116 sites across 16 countries: Australia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, South Africa, Spain, Sweden