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 Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism).

Trial Profile

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 Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism).

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jun 2014

At a glance

  • Drugs Apixaban (Primary) ; Enoxaparin sodium
  • Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms ADVANCE-3
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 14 Mar 2014 Apixaban (sNDA) approved by the US FDA based on results of ADVANCE-1, -2 and -3 trials, according to a Bristol-Myers Squibb Company and Pfizer media release.
    • 11 Jul 2013 Supplemental New Drug Application for apixaban accepted for review by the US FDA based on results of ADVANCE-1, -2 and -3 trials, according to Bristol-Myers Squibb Company and Pfizer media release.
    • 04 Jul 2012 Company added in the association field as reported by EudraCT.
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