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A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention

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Trial Profile

A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 13 Dec 2023

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At a glance

  • Drugs Apixaban (Primary) ; Enoxaparin sodium; Enoxaparin sodium; Warfarin
  • Indications Thromboembolism
  • Focus Adverse reactions
  • Acronyms SAXOPHONE
  • Sponsors Bristol-Myers Squibb

    • Most Recent Events

    • 12 Dec 2023 Results reporting safety and efficacy data published in the Journal of the American College of Cardiology
    • 24 Mar 2023 Results (n=124) of an analysis evaluating dosing apixaban pharmacokinetics and pharmacodynamics in pediatric patients with CAHD using data from this trial presented at the 124th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 23 Nov 2021 Status changed from recruiting to completed.
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