A Phase 3, Randomized, Double-Blind, Active-Controlled (Enoxaparin 40 mg QD), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study).

Trial Profile

A Phase 3, Randomized, Double-Blind, Active-Controlled (Enoxaparin 40 mg QD), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study).

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Nov 2016

At a glance

  • Drugs Apixaban (Primary) ; Enoxaparin sodium
  • Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms ADVANCE-2
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 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.
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