Trials / Completed
CompletedNCT02234843
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of an age-and Body Weight-adjusted Rivaroxaban Regimen Compared to Standard of Care in Children With Acute Venous Thromboembolism
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivaroxaban (Xarelto, BAY59-7939) | Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily or twice daily, as tablets |
| DRUG | Rivaroxaban (Xarelto, BAY59-7939) | Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily, twice daily or three times daily, as oral suspension |
| DRUG | Standard of Care | LMWH (low molecular weight heparin) or fondaparinux or vitamin K antagonist (VKA) therapy. dose : as per standard of care |
Timeline
- Start date
- 2014-11-13
- Primary completion
- 2019-01-30
- Completion
- 2019-01-30
- First posted
- 2014-09-09
- Last updated
- 2020-04-01
- Results posted
- 2020-04-01
Locations
109 sites across 28 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Russia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02234843. Inclusion in this directory is not an endorsement.