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

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.
 
ClinicalTrials.gov Identifier: NCT01145859
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : August 6, 2015
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism
Study Start Date : November 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Arm 1 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults




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

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


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

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


Locations
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United States, Arkansas
Little Rock, Arkansas, United States, 72202-3500
United States, California
Los Angeles, California, United States, 90027-6089
Los Angeles, California, United States, 90095
Orange, California, United States, 92868
United States, Florida
Gainesville, Florida, United States, 32610
St. Petersburg, Florida, United States, 33701
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Indiana
Indianapolis, Indiana, United States, 46202
Indianapolis, Indiana, United States, 46260
United States, Michigan
Detroit, Michigan, United States, 48201-2196
United States, New York
New Hyde Park, New York, United States, 11040
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland, Ohio, United States, 44106-6007
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15224
Australia, Queensland
Brisbane, Queensland, Australia, 4029
Australia, Victoria
Parkville, Victoria, Australia, 3052
Austria
Linz, Austria, 4020
Wien, Austria, 1090
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1C9
Canada, Ontario
Hamilton, Ontario, Canada, L8N 3Z5
Toronto, Ontario, Canada, M5G 1X8
France
CLERMONT-FERRAND Cedex 1, France, 63003
Montpellier, France, 34059
Paris, France, 75015
TOULOUSE Cedex 9, France, 31059
Germany
Lübeck, Schleswig-Holstein, Germany, 23538
Ireland
Crumlin, Dublin, Ireland, 12
Israel
Jerusalem, Israel, 9112001
Tel Hashomer, Israel, 5262000
Italy
Genova, Italy, 16147
Milano, Italy, 20122
Pavia, Italy, 27100
Torino, Italy, 10126
Switzerland
Basel, Basel-Stadt, Switzerland, 4056
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
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Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01145859    
Other Study ID Numbers: 12892
2009-017313-30 ( EudraCT Number )
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015
Keywords provided by Bayer:
Venous Thrombosis
Pediatrics
Additional relevant MeSH terms:
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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