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

Venous Thrombosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01145859
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 1
Start date November 2010
Completion date July 2015
View Details
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