Dose-confirmatory Bridging Study in Total Hip Replacement

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).

Timeline

Start

2010-09

Primary completion

2011-06

Completion

2011-08

Drugs

Indications