Status:
COMPLETED
Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Venous Thrombosis
Pediatrics
Eligibility:
All Genders
6-18 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01145859
Start Date
November 1 2010
End Date
July 1 2015
Last Update
August 6 2015
Active Locations (36)
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1
Little Rock, Arkansas, United States, 72202-3500
2
Los Angeles, California, United States, 90027-6089
3
Los Angeles, California, United States, 90095
4
Orange, California, United States, 92868