Overview

Dose-confirmatory Bridging Study in Total Knee Replacement

Status:
Completed
Trial end date:
2011-06-01
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 knee replacement (TKR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.
Phase:
Phase 3
Details
Lead Sponsor:
Bayer
Collaborator:
Janssen Scientific Affairs, LLC
Treatments:
Enoxaparin
Rivaroxaban