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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 August 2015 |
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Main ID: |
NCT01145859 |
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Date of registration:
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16/06/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
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Scientific title:
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Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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59 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01145859 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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Austria
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Canada
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France
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Germany
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Ireland
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Israel
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Italy
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Switzerland
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United States
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Months
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pediatrics
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Venous Thrombosis
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Intervention(s)
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Drug: Rivaroxaban (Xarelto, BAY59-7939)
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Primary Outcome(s)
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Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)
[Time Frame: From Day 1 to Day 2]
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Pharmacokinetics parameters (AUC and Cmax)
[Time Frame: From Day 1 to Day 2]
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Secondary Outcome(s)
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Safety and tolerability of rivaroxaban in pediatric subjects
[Time Frame: Day 1, day 2 plus 7 days follow up]
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Secondary ID(s)
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2009-017313-30
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12892
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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