drugset / Trial / NCT00709904

Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery

NCT00709904

Phase 3 Completed 469 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery. The secondary objective is to evaluate the safety of extended AVE5026 administration.

Timeline

Start
2008-06
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Semuloparin Other / unclassified 10 mg Subcutaneous
Subject Semuloparin Other / unclassified 20 mg Subcutaneous