At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 9 enrolled
Drug / intervention
dabigatran etexilatedrug
Likely dose
dabigatran etexilate 2.14 mg/kgfrom 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 Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given for 3 Days at the End of Standard Anticoagulant Therapy in Children Aged 12 Years to Less Than 18 Years
In Brief
A Phase 2 clinical trial evaluating dabigatran etexilate for Venous Thromboembolism. Completed, enrolled 9 participants across 2 sites.
Detailed Summary
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartJun 2009
Primary CompletionFeb 2012
TodayJul 2026
First PostedFeb 16, 2009
Enrollment StartJun 1, 2009
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.4 years ago
Interventions
dabigatran etexilatedrug
2.14 mg/kg BID to a max 150 mg BID