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Oral Rivaroxaban in Children With Venous Thrombosis

NCT01684423 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-09-21

Study results available
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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.

Conditions

  • Venous Thrombosis

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

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.

DRUG

Active comparator

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).

DRUG

Rivaroxaban (BAY59-7939) suspension

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-19
Primary Completion
2016-09-01
Completion
2016-09-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01684423 on ClinicalTrials.gov