A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
This study has been completed.
Daiichi Sankyo Inc.
Daiichi Sankyo Co., Ltd.
Information provided by:
Daiichi Sankyo Inc.
First received: September 14, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
The objective of this study is to compare the efficacy, safety at each dose versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.
Embolism and Thrombosis
Deep Vein Thrombosis
Arthroplasty, Replacement, Hip
Drug: DU-176V 15 mg tablets oral, once daily for 2 weeks
Drug: DU-176b 30 mg tablets, oral once daily for 2 weeks
Drug: Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- Proportion of subjects with venous thromboembolism events [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects with bleeding events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Experimental: DU-176b 30 mg||Drug: DU-176b 30 mg tablets, oral once daily for 2 weeks|
|Active Comparator: Enoxaparin sodium||Drug: Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous|
|Experimental: DU-176b 15 mg||Drug: DU-176V 15 mg tablets oral, once daily for 2 weeks|
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