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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 May 2022

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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

    • 16 May 2022 Data from ARISTOTLE: NCT00412984; AVERROES: NCT00496769; AMPLIFY: NCT00643201; AMPLIFY-EXT: NCT00633893; ADVANCE-1: NCT00371683; ADVANCE-2: NCT00452530; ADVANCE-3: NCT00423319 studies has been used to assess apixaban use in obese patients published in the American Journal of Cardiovascular Drugs
    • 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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