At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 8 enrolled
Drug / intervention
dabigatrandrug
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.
Open-label, Single Dose, Tolerability, Pharmacokinetic/Pharmacodynamics and Safety Study of Dabigatran Etexilate Given at the End of Standard Anticoagulant Therapy in Children Aged Less Than 1 Year Old
In Brief
A Phase 2 clinical trial evaluating dabigatran for Venous Thromboembolism. Completed, enrolled 8 participants across 4 sites in 3 countries.
Detailed Summary
The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesCanada, France, Russia
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartSep 2014
Primary CompletionJan 2016
Study CompletionFeb 2016
TodayJul 2026
First PostedAug 22, 2014
Enrollment StartSep 1, 2014
Primary CompletionJan 1, 2016
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.9 years ago
Interventions
dabigatrandrug
Experimental dose chosen based on age and weight