Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism

Trial Profile

Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism

Recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Rivaroxaban (Primary) ; Enoxaparin sodium; Fondaparinux sodium; Warfarin
  • Indications Venous thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EINSTEIN Junior Phase III
  • Sponsors Bayer; Bayer HealthCare; Janssen Research & Development
  • Most Recent Events

    • 10 May 2017 This trial has been completed in Ireland (5 Apr 2017).
    • 17 Mar 2017 Planned End Date changed from 1 Aug 2018 to 4 Jul 2019.
    • 17 Mar 2017 Planned primary completion date changed from 1 Jul 2018 to 4 Jul 2019.
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