drugset / Trial / NCT00714597

Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

NCT00714597

Phase 3 Terminated 421 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary objective was to compare the efficacy of once daily \[q.d\] subcutaneous \[s.c.\] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events \[VTE\] in patients hospitalized for acute medical illness. The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.

Timeline

Start
2008-07
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enoxaparin sodium Other / unclassified 20 mg Subcutaneous
Comparator Enoxaparin sodium Other / unclassified 40 mg Subcutaneous
Subject Semuloparin Other / unclassified 10 mg Subcutaneous
Subject Semuloparin Other / unclassified 20 mg Subcutaneous