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A Phase 3, Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery...

Mise à jour : Il y a 5 ans
Référence : EUCTR2006-005351-14

A Phase 3, Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The ADVANCE-3 study Apixaban Dosed Orally Versus Anti-Coagulation with Injectable Enoxaparin to Prevent Venous Thromboembolism) +Pharmacogenetics Blood Sample Amendment 01 (Version 1.0 - dated 27-Nov-2006) Revised Protocol 02, incorporating Protocol Amedment 02 & 04 and Admin Letter 01 (Version 3.0, Dated 21-Jun-2007)

Femme et Homme

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Extrait

To compare the effect of oral (PO) apixaban 2.5 mg BID versus subcutaneous (SC) enoxaparin 40 mg QD on the composite endpoint of adjudicated asymptomatic and symptomatic deep-vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and all cause death during 35 days of double-blind treatment in subjects undergoing elective total hip replacement surgery.

Critère d'inclusion

  • Subjects undergoing elective total hip replacement (THR) surgery

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