Trials / Completed
CompletedNCT02197416
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
Open Label, Single Arm Safety Prospective Cohort Study of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Children From 0 to Less Than 18 Years
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 214 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dabigatran etexilate | Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation |
Timeline
- Start date
- 2014-09-29
- Primary completion
- 2019-10-16
- Completion
- 2019-11-19
- First posted
- 2014-07-22
- Last updated
- 2020-06-04
- Results posted
- 2020-06-04
Locations
62 sites across 22 countries: United States, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Lithuania, Mexico, Norway, Russia, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine
Source: ClinicalTrials.gov record NCT02197416. Inclusion in this directory is not an endorsement.