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

Completed · Phase 1

Conditions studied: Venous Thrombosis, Pediatrics

In brief

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.

Key facts

Study ID

NCT01145859

Run by

Bayer

People needed

59

Starts

2010-11-01

Expected to finish

2015-07-01

Last updated by the study team

2015-08-06

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — Gainesville, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Detroit, Michigan, United States
• Study site — New Hyde Park, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Brisbane, Queensland, Australia
• Study site — Parkville, Victoria, Australia
• Study site — Vienna, State of Vienna, Austria
• Study site — Linz, Austria
• Study site — Edmonton, Alberta, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Clermont-Ferrand, France
• Study site — Montpellier, France

Full record on ClinicalTrials.gov

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