Overview

Dose-confirmatory Bridging Study in Total Hip Replacement

Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing elective total hip replacement (THR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase II study (ODIXa-OD.HIP - Study 11527).
Phase:
Phase 3
Details
Lead Sponsor:
Bayer
Collaborator:
Janssen Research & Development, LLC
Treatments:
Enoxaparin
Rivaroxaban