NCT01203072

A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

A Phase 2b, Randomized, Double-Blind, Multi-Dose Efficacy, Safety and Dose-finding Study of the Oral Factor Xa Inhibitor DU-176b Compared With Placebo for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS J-1)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 523 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Conditions

• Venous Thromboembolism
• Deep Vein Thrombosis
• Total Knee Arthroplasty

Interventions

Type	Name	Description
DRUG	DU-176b	DU-176b 5mg tablets oral, once daily for 2 weeks
DRUG	DU-176b	DU-176b 15mg tablets, oral once daily for 2 weeks
DRUG	DU-176b	DU-176b 30 mg tablets, oral, once daily for 2 weeks
DRUG	DU-176b	DU-176b 60 mg tablets, oral, once daily for 2 weeks
DRUG	Placebo	Matching placebo oral tablets, once daily for 2 weeks

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-09-01
• Completion: 2008-07-01
• First posted: 2010-09-16
• Last updated: 2019-02-25
• Results posted: 2015-01-26

Locations

2 sites across 1 country: Japan