NCT01145859

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thrombosis
• Pediatrics

Interventions

Type	Name	Description
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults

Timeline

• Start date: 2010-11-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2010-06-17
• Last updated: 2015-08-06

Locations

36 sites across 10 countries: United States, Australia, Austria, Canada, France, Germany, Ireland, Israel, Italy, Switzerland