Conditions: Venous Thromboembolism
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief summary:
The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.

Detailed description:
Purpose:

Arms:
arm 1: open label arm with dabigatran oral liquid formulation as single dose

Interventions: intervention 1: dabigatran
Intervention descriptions: intervention 1: Experimental dose chosen based on age and weight

Protocol document: