NCT00168805

RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery

RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,101 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s \[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

Conditions

• Arthroplasty, Replacement, Knee
• Thromboembolism

Interventions

Type	Name	Description
DRUG	enoxaparin	40 mg once daily
DRUG	dabigatran etexilate	150 mg once daily
DRUG	dabigatran etexilate	220 mg once daily

Timeline

• Start date: 2004-11-01
• Primary completion: 2006-05-01
• First posted: 2005-09-15
• Last updated: 2014-05-19
• Results posted: 2010-12-17

Locations

105 sites across 15 countries: Australia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, South Africa, Spain, Sweden