Open-label, Randomized, Parallel-group, Active-controlled, Multi-centre Non-inferiority Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment in Children From Birth to Less Than 18 Years of Age

Trial Profile

Open-label, Randomized, Parallel-group, Active-controlled, Multi-centre Non-inferiority Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment in Children From Birth to Less Than 18 Years of Age

Recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Dabigatran etexilate (Primary) ; Low molecular weight heparins; Vitamin K antagonists
  • Indications Venous thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms DIVERSITY
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 06 Dec 2016 Trial design presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 02 Dec 2016 Planned number of patients changed from 270 to 180.
    • 02 Dec 2016 Planned End Date changed from 1 Mar 2018 to 1 Jun 2018.
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