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: 30 Dec 2016

At a glance

  • Drugs Dabigatran etexilate (Primary)
  • Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 06 Dec 2016 Results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 28 Apr 2016 The study is "Prematurely ended" in Austria, Netherlands, Lithuania and Latvia.
    • 23 Feb 2016 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
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