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

This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01145859
First received: June 16, 2010
Last updated: May 31, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Venous Thrombosis
Pediatrics
 Drug: Rivaroxaban (Xarelto, BAY59-7939)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism

Resource links provided by NLM:

Drug Information available for: Rivaroxaban
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacokinetics parameters (AUC and Cmax) [ Time Frame: From Day 1 to Day 2 ] [ Designated as safety issue: No ]
  • Pharmacodynamics parameters (PT, aPTT and anti-factor Xa) [ Time Frame: From Day 1 to Day 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of rivaroxaban in pediatric subjects [ Time Frame: Day 1, day 2 plus 7 days follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: November 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric subjects > 6 months and < 18 years of age at the time of administration of study drug.
  • Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE

Exclusion Criteria:

  • Any major or clinically relevant bleeding during prior VTE treatment
  • Abnormal coagulation tests within 7 days prior to study drug administration
  • Severe renal impairment
  • Planned invasive procedures prior to or after 24 hours of study drug administration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145859

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 28 Study Locations
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01145859     History of Changes
Other Study ID Numbers: 12892, 2009-017313-30
Study First Received: June 16, 2010
Last Updated: May 31, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care
Canada: Ethics Review Committee
Canada: Health Canada
Israel: Ethics Commission
Israel: Ministry of Health
Italy: Ethics Committee
Italy: National Institute of Health
United States: Food and Drug Administration
United States: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Switzerland: Swissmedic

Keywords provided by Bayer:
Venous Thrombosis
Pediatrics

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on June 17, 2013