CompletedPhase 1

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

United States59 participantsStarted 2010-11

Plain-language 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 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.

Who can participate

Age range6 Months – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pharmacokinetics parameters (AUC and Cmax)

Timeframe: From Day 1 to Day 2

Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)

Timeframe: From Day 1 to Day 2

Trial details

NCT IDNCT01145859

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07

View on ClinicalTrials.gov More Venous Thrombosis trials