Trials / Completed
CompletedNCT02309411
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Young Children With Various Manifestations of Venous Thrombosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 6 Months – 5 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivaroxaban (Xarelto, BAY59-7939) | With age and body-weight adjusted twice daily dosing of rivaroxaban as Oral Suspension to achieve a similar exposure as that observed in adults treated with 20 mg rivaroxaban once daily, and no other anticoagulant |
Timeline
- Start date
- 2015-01-15
- Primary completion
- 2017-04-05
- Completion
- 2017-04-05
- First posted
- 2014-12-05
- Last updated
- 2018-08-21
- Results posted
- 2018-06-13
Locations
29 sites across 15 countries: United States, Australia, Austria, Brazil, Canada, Hungary, Israel, Italy, Japan, Netherlands, Poland, Russia, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02309411. Inclusion in this directory is not an endorsement.