Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
NCT ID: NCT01145859
Last Updated: 2015-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2010-11-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Arm 1
Rivaroxaban (Xarelto, BAY59-7939)
Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults
Eligibility Criteria
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Inclusion Criteria
* Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE
Exclusion Criteria
* 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
6 Months
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Little Rock, Arkansas, United States
Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
Gainesville, Florida, United States
St. Petersburg, Florida, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Detroit, Michigan, United States
New Hyde Park, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Brisbane, Queensland, Australia
Parkville, Victoria, Australia
Vienna, Vienna, Austria
Linz, , Austria
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Clermont-Ferrand, , France
Montpellier, , France
Paris, , France
Toulouse, , France
Lübeck, Schleswig-Holstein, Germany
Crumlin, Dublin, Ireland
Jerusalem, , Israel
Tel Litwinsky, , Israel
Genova, , Italy
Milan, , Italy
Pavia, , Italy
Torino, , Italy
Basel, Canton of Basel-City, Switzerland
Countries
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References
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Willmann S, Thelen K, Kubitza D, Lensing AWA, Frede M, Coboeken K, Stampfuss J, Burghaus R, Muck W, Lippert J. Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:32. doi: 10.1186/s12959-018-0185-1. eCollection 2018.
Kubitza D, Willmann S, Becka M, Thelen K, Young G, Brandao LR, Monagle P, Male C, Chan A, Kennet G, Martinelli I, Saracco P, Lensing AWA. Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:31. doi: 10.1186/s12959-018-0186-0. eCollection 2018.
Willmann S, Becker C, Burghaus R, Coboeken K, Edginton A, Lippert J, Siegmund HU, Thelen K, Muck W. Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban. Clin Pharmacokinet. 2014 Jan;53(1):89-102. doi: 10.1007/s40262-013-0090-5.
Other Identifiers
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2009-017313-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12892
Identifier Type: -
Identifier Source: org_study_id
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