Venous Thromboembolism Treatment with Dabigatran: The DIVERSITY Study – Phase III

Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment 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 venous thromboembolism (VTE), a blood clotting disorder, and to compare their results to participants using either a vitamin K antagonist (VKA) or low-molecular-weight heparin (LMWH), both of which are approved prescription medications used to treat blood clots. The study drug, which has been approved for use in adults, is a blood thinner that may help to prevent VTE.

Study Level: Phase III

Eligibility Criteria

This study is accepting patients of both genders, through age 17, diagnosed with a VTE that requires treatment with anticoagulants (blood thinners) for a period of at least 3 months.
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 either the study drug (dabigatran) or will be prescribed an alternative standard medication (either VKA or LMWH). Return visits for exams and testing will be scheduled, and parents/caregiviers will need to keep a journal tracking the child’s drug intake over the study duration.
Visits: About 9
Duration: Approximately 4 months

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