Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
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.