Single dose open-label PK/PD, safety and tolerability study of dabigatran etexilate mesilate given at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years followed by 1 year to less than 2 years

Trial Profile

Single dose open-label PK/PD, safety and tolerability study of dabigatran etexilate mesilate given at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years followed by 1 year to less than 2 years

Completed
Phase of Trial: Phase II

Latest Information Update: 16 Sep 2017

At a glance

  • Drugs Dabigatran etexilate (Primary)
  • Indications Venous thromboembolism
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Boehringer Ingelheim; Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 16 Sep 2017 A protocol has amended to change at least eight patients in each age group to at least four patients in the younger age group according to results published in the Journal of Thrombosis and Haemostasis
    • 16 Sep 2017 Results published in the Journal of Thrombosis and Haemostasis
    • 06 Dec 2016 Results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
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