Overview

Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

Status:
Completed

Trial end date:
2019-11-14

Target enrollment:

Participant gender:

Summary

The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

Phase:

Phase 3

Details

Lead Sponsor:

Boehringer Ingelheim

Treatments:

Dabigatran
Dalteparin
Heparin, Low-Molecular-Weight