At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 66 enrolled
Drug / intervention
Edoxaban low dose +1 moredrug
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.
A Phase 1, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients
In Brief
A Phase 1 clinical trial evaluating Edoxaban low dose and Edoxaban high dose for Deep Vein Thrombosis and Venous Thromboembolism. Completed, enrolled 66 participants across 35 sites in 9 countries.
Detailed Summary
This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDeep Vein Thrombosis, Venous Thromboembolism
CountriesCanada, France, India, Italy, Lebanon, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedDec 2014
Primary CompletionSep 2021
TodayJul 2026
First PostedDec 1, 2014
Enrollment StartNov 5, 2014
Primary CompletionSep 16, 2021
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 11.6 years ago
Interventions
Edoxaban low dosedrug
Edoxaban low dose
Edoxaban high dosedrug
Edoxaban high dose