At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 46 enrolled
Drug / intervention
Rivaroxaban (Xarelto, BAY59-7939)drug
Likely dose
Rivaroxaban (Xarelto, BAY59-7939) 20 mgfrom 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.
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
In Brief
A Phase 2 clinical trial evaluating Rivaroxaban (Xarelto, BAY59-7939) for Venous Thromboembolism. Completed, enrolled 46 participants across 29 sites in 15 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesAustralia, Austria, Brazil, Canada, Hungary, Israel, Italy, Japan, Netherlands, Poland, Russia, Spain, Switzerland, United Kingdom, United States
CollaboratorsJanssen Research & Development, LLC
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartJan 2015
Primary CompletionApr 2017
TodayJul 2026
First PostedDec 5, 2014
Enrollment StartJan 15, 2015
Primary CompletionApr 5, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.6 years ago
Interventions
Rivaroxaban (Xarelto, BAY59-7939)drug
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