At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
dabigatran etexilatedrug
Likely dose
Not stated in 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.
Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Successive Groups of Children Aged 2 Years to Less Than 12 Years Followed by 1 Year to Less Than 2 Years
In Brief
A Phase 2 clinical trial evaluating dabigatran etexilate for Venous Thromboembolism. Completed, enrolled 18 participants across 7 sites in 6 countries.
Detailed Summary
To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesCanada, Italy, Lithuania, Russia, Switzerland, Thailand
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionFeb 2016
TodayJul 2026
First PostedMar 10, 2010
Enrollment StartMar 1, 2010
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 16.3 years ago
Interventions
dabigatran etexilatedrug
Experimental dose chosen based on age and weight