Trial intelligence / Profile preview

Single-dose pharmacokinetics, pharmacodynamics, tolerability and safety of dabigatran etexilate in infants under 1 year at the end of standard anticoagulant therapy

2014-001259-22Phase 2Completed

Sponsor
Boehringer Ingelheim
Start
Jul 2014
Modality
Small Molecules
Countries
1
01

Overview

Phase 2, open-label, single-arm trial of dabigatran in venous thromboembolism (VTE) and Phlebothrombosis, sponsored by Boehringer Ingelheim. Primary endpoints: Total dabigatran plasma concentration at 2 hours post dose and Total dabigatran plasma concentration at 12 hours post dose. Started Jul 2014; status: completed.

02

Drugs

dabigatran
03

Conditions

venous thromboembolism (VTE)Phlebothrombosis

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