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An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events

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Trial Profile

An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Feb 2024

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At a glance

  • Drugs Edoxaban (Primary) ; Aspirin; Enoxaparin sodium; Heparin; Phenprocoumon; Warfarin
  • Indications Thromboembolism
  • Focus Adverse reactions
  • Acronyms ENNOBLE-ATE
  • Sponsors Daiichi Sankyo Company; Daiichi Sankyo Inc
  • Most Recent Events

    • 12 Oct 2022 Results reporting efficacy and safety data published in the Journal of the American College of Cardiology
    • 20 Jan 2022 This trial has been completed in France (Date of the global end of the trial : 03-Dec-2021), according to European Clinical Trials Database record.
    • 18 Jan 2022 Status changed from recruiting to completed.
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