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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

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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

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 11 Apr 2022

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At a glance

  • Drugs Dabigatran etexilate (Primary) ; Fondaparinux sodium; Low molecular weight heparins; Vitamin K antagonists
  • Indications Venous thromboembolism
  • Focus Registrational; Therapeutic Use
  • Acronyms DIVERSITY
  • Sponsors Boehringer Ingelheim; Boehringer Ingelheim Pharma KG

    • Most Recent Events

    • 15 Nov 2021 Results presented at the American Heart Association Scientific Sessions 2021
    • 26 Feb 2021 Results of population Pharmacokinetic Modeling and Simulation Support from five trials ((NCT02223260, NCT01083732, NCT00844415, NCT01895777, NCT02197416) published in the Journal of Thrombosis and Haemostasis
    • 08 Dec 2020 Results of sub-group analysis of two phase IIb/III DE trials assessing efficacy and safety of dabigatran etexilate for the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia, presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology.

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