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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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Jan 2022

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At a glance

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

    • Most Recent Events

    • 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
    • 15 Aug 2018 Results published in the Thrombosis and Haemostasis
    • 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
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