Venous Thromboembolism Prevention with Dabigatran – Phase III

Study of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Children

Protocol Description

The purpose of this multi-center research study is to test the investigational drug dabigatran etexilate in pediatric patients who have had venous thromboembolism (VTE), a blood clotting disorder. The study drug, which has been approved for use in adults, is a blood thinner that may help to prevent recurrent VTE, which is a risk factor for patients who have already had VTE.

Study Level: Phase III

Eligibility Criteria

This study is accepting patients of both genders, through age 17, who previously had a VTE treated with blood-thinning drugs for at least 3 months or have completed treatment in the related DIVERSITY Study. Participants must still have a risk factor for VTE and require further treatment with blood thinning drugs for secondary prevention of VTE.
Males and Females: Through age 17


The study begins with a screening visit that includes a physical exam and various medical tests. Participants will be provided the study drug, to be taken twice daily for the duration of the study period. Return visits for exams and testing occur over increasingly extended intervals ranging from 1 week, initially, to up to 8 weeks for the latter part of the study.
Visits: 12
Duration: Approximately 1 year

Status: Open to Enrollment

Source(s) of Support

Boehringer Ingelheim Pharmaceuticals

Primary Investigator

James D. Cooper, MD

Contact Information

For more information about the study or enrollment, please contact:
Angela Martino, BSN, RN