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

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any - 18
Updated:	4/21/2016
Start Date:	November 2010
End Date:	July 2015

Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism

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.

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

We found this trial at

sites

Clinical Trial Facility in Chapel Hill North Carolina

Chapel Hill, North Carolina

from

Chapel Hill, NC