drugset

drugset / Trial / NCT00844415

Safety and Tolerability of Dabigatran Etexilate in Adolescents

NCT00844415 ↗

Phase 2 Completed 9 enrolled Boehringer Ingelheim

Non-randomizedSingle-groupOpen-labelTreatment

Summary

To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.

Timeline

Start: 2009-06-01
Primary completion: 2012-02-01
Completion: —

Publications

Halton JM, Lehr T, Cronin L, Lobmeyer MT, Haertter S, Belletrutti M, Mitchell LG. Safety, tolerability and clinical pharmacology of dabigatran etexilate in adolescents. An open-label phase IIa study. Thromb Haemost. 2016 Aug 30;116(3):461-71. doi: 10.1160/TH15-04-0275. Epub 2016 Jun 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dabigatran etexilate	Unknown	2.14 mg/kg	—

Indications