NCT00152971

Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,615 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery

Conditions

• Arthroplasty, Replacement, Knee
• Thromboembolism

Interventions

Type	Name	Description
DRUG	Dabigatran Dose 1 - day 2 to completion	low dose regimen taken once daily
DRUG	Dabigatran Dose 1 - day 1	low dose regimen taken once daily
DRUG	Dabigatran Dose 2 - day 2 to completion	high dose regimen taken once daily
DRUG	Dabigatran Dose 2 - day 1	high dose regimen taken once daily
DRUG	Enoxaparin	30 mg subcutaneously twice daily

Timeline

• Start date: 2004-11-01
• Primary completion: 2006-06-01
• First posted: 2005-09-12
• Last updated: 2014-05-05
• Results posted: 2010-12-17

Locations

94 sites across 4 countries: United States, Canada, Mexico, United Kingdom