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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01145859
First Posted: June 17, 2010
Last Update Posted: August 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacokinetics parameters (AUC and Cmax) [ Time Frame: From Day 1 to Day 2 ]
  • Pharmacodynamics parameters (PT, aPTT and anti-factor Xa) [ Time Frame: From Day 1 to Day 2 ]

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

Enrollment: 59
Study Start Date: November 2010
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145859


  Show 36 Study Locations
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01145859     History of Changes
Other Study ID Numbers: 12892
2009-017313-30 ( EudraCT Number )
First Submitted: June 16, 2010
First Posted: June 17, 2010
Last Update Posted: August 6, 2015
Last Verified: August 2015

Keywords provided by Bayer:
Venous Thrombosis
Pediatrics

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants