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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran

Criteria

Inclusion criteria:

• Neonates and infants with aged < 12 months at Visit 1

• Objective diagnosis of VTE

• End of planned treatment course with anticoagulant therapy as per standard of care at the investigator site.

• Written informed consent provided by the patient's parent(s) (or legal guardian) according to local regulations at Visit 1.

Exclusion criteria:

• Weight less than 3 kg at Visit 1

• Conditions associated with an increased risk of bleeding

• renal dysfunction

• hepatic disease

• Anemia or thrombocytopenia at screening