A phase 3 randomized, double-blind active-controlled (enoxaparin), parallel-group, multi-center study to evaluate the safety and efficacy of oral apixaban in subjects undergoing elective total knee replacement surgery

Trial Profile

A phase 3 randomized, double-blind active-controlled (enoxaparin), parallel-group, multi-center study to evaluate the safety and efficacy of oral apixaban in subjects undergoing elective total knee replacement surgery

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jan 2016

At a glance

  • Drugs Apixaban (Primary) ; Enoxaparin sodium
  • Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ADVANCE-1
  • 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.
    • 06 Aug 2009 Results were published in the New England Journal of Medicine 361: 594-604, No. 6, 6 Aug 2009.
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