At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 229 enrolled
Drug / intervention
Apixaban +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 Randomized, Open-Label, Active Controlled, Safety and Descriptive Efficacy Study in Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event
In Brief
A Phase 4 clinical trial evaluating Apixaban and Standard of Care for Venous Thromboembolism. Completed, enrolled 229 participants across 128 sites in 13 countries.
Detailed Summary
To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesAustralia, Austria, Canada, France, Germany, Israel, Mexico, Russia, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsPfizer
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartNov 2015
Primary CompletionApr 2024
TodayJul 2026
First PostedJun 8, 2015
Enrollment StartNov 22, 2015
Primary CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 11.1 years ago
Interventions
Apixabandrug
Tablet or Solution
Standard of Caredrug
Unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For subjects under 2 years of age, standard of care will be limited to unfractionated heparin or low molecular weight heparin.