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Withdrawn prior to enrolment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
- 23 Oct 2015 Status changed from recruiting to withdrawn prior to enrolment, according to ClinicalTrials.gov record.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.