drugset / Trial / NCT00718224

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery

NCT00718224

Phase 3 Completed 1150 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing elective knee replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective knee replacement surgery, and to document AVE5026 exposure in this population.

Timeline

Start
2008-07
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enoxaparin sodium Other / unclassified 20 mg Subcutaneous
Comparator Enoxaparin sodium Other / unclassified 30 mg Subcutaneous
Subject Semuloparin Other / unclassified 10 mg Subcutaneous
Subject Semuloparin Other / unclassified 20 mg Subcutaneous