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Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects

NCT01145859 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2015-08-06

No results posted yet for this study

Summary

The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.

Conditions

  • Venous Thrombosis
  • Pediatrics

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • 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 NCT01145859 on ClinicalTrials.gov