Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Children Aged 1 Year to Less Than 2 Years in Conjunction With Study 1160.89

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 Children Aged 1 Year to Less Than 2 Years in Conjunction With Study 1160.89

Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 29 Oct 2015

At a glance

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

    • 23 Oct 2015 Status changed from recruiting to withdrawn prior to enrolment, according to ClinicalTrials.gov record.
    • 04 Aug 2015 Planned number of patients changed from 6 to 5 as reported by ClinicalTrials.gov.
    • 06 Aug 2014 According to the ClinicalTrials.gov record, planned end date changed from 1 Dec 2014 to 1 Dec 2015.
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