CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Rivaroxaban (Xarelto, BAY59-7939) +2 moredrug
Likely dose
Not stated in 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.

Search/NCT01684423
NCT01684423Phase 2Completed
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30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis

Bayer·interventional·Posted Sep 13, 2012·Updated Sep 21, 2017

In Brief

A Phase 2 clinical trial evaluating Rivaroxaban (Xarelto, BAY59-7939), Active comparator, and 1 other intervention for Venous Thrombosis. Completed, enrolled 64 participants across 59 sites in 10 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. There will also be a check for bleeding and worsening of blood clots.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thrombosis
CountriesAustralia, Austria, Canada, France, Germany, Israel, Italy, Netherlands, Switzerland, United States
CollaboratorsJanssen Research & Development, LLC

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2012
Enrollment StartFeb 19, 2013
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.8 years ago

Interventions

Rivaroxaban (Xarelto, BAY59-7939)drug

Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.

Active comparatordrug

Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).

Rivaroxaban (BAY59-7939) suspensiondrug

Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.