drugset / Trial / NCT00152971

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

NCT00152971

Phase 3 Completed 2615 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindPrevention

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

Timeline

Start
2004-11
Primary completion
2006-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran etexilate Unknown 75 mg Oral
Subject Dabigatran etexilate Unknown 110 mg Oral
Subject Dabigatran etexilate Unknown 150 mg Oral
Subject Dabigatran etexilate Unknown 220 mg Oral
Comparator Enoxaparin sodium Other / unclassified 30 mg Subcutaneous