Trials / Completed
CompletedNCT02464969
Apixaban for the Acute Treatment of Venous Thromboembolism in Children
A Randomized, Open-Label, Active Controlled, Safety and Descriptive Efficacy Study in Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 229 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 0 Days – 17 Years
- Healthy volunteers
- Not accepted
Summary
To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apixaban | Tablet or Solution |
| DRUG | Standard of Care | 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. |
Timeline
- Start date
- 2015-11-22
- Primary completion
- 2024-04-30
- Completion
- 2024-04-30
- First posted
- 2015-06-08
- Last updated
- 2024-10-29
- Results posted
- 2024-10-29
Locations
128 sites across 13 countries: United States, Australia, Austria, Canada, France, Germany, Israel, Mexico, Russia, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT02464969. Inclusion in this directory is not an endorsement.