Trials / Completed
CompletedNCT02981472
A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation
A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 192 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 28 Days – 17 Years
- Healthy volunteers
- Not accepted
Summary
To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apixaban | Specified dose on specified days |
| DRUG | Vitamin K Antagonist (VKA) | Specified dose on specified days |
| DRUG | Low Molecular Weight Heparin (LMWH) | Specified dose on specified days |
Timeline
- Start date
- 2017-01-19
- Primary completion
- 2021-10-18
- Completion
- 2021-10-18
- First posted
- 2016-12-05
- Last updated
- 2022-10-03
- Results posted
- 2022-05-18
Locations
46 sites across 14 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Finland, Germany, Israel, Italy, Mexico, Russia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02981472. Inclusion in this directory is not an endorsement.