At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 214 enrolled
Drug / intervention
dabigatran etexilatedrug
Likely dose
dabigatran etexilate 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating dabigatran etexilate for Venous Thromboembolism and Secondary Prevention. Completed, enrolled 214 participants across 62 sites in 22 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism, Secondary Prevention
CountriesAustria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Lithuania, Mexico, Norway, Russia, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartSep 2014
Primary CompletionOct 2019
Study CompletionNov 2019
TodayJul 2026
First PostedJul 22, 2014
Enrollment StartSep 29, 2014
Primary CompletionOct 16, 2019
Study CompletionNov 19, 2019
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 11.9 years ago
Interventions
dabigatran etexilatedrug
Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation