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
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
- 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.