Trials / Completed
CompletedNCT01203098
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 264 (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 compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.
Conditions
- Venous Thromboembolism
- Thromboembolism
- Thrombosis
- Embolism and Thrombosis
- Deep Vein Thrombosis
- Arthroplasty, Replacement, Hip
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DU-176b 15mg | DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery. |
| DRUG | DU-176b 30mg | DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery. |
| DRUG | Enoxaparin sodium 20 mg (=2000IU) | Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery. |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2008-12-01
- Completion
- 2009-06-01
- First posted
- 2010-09-16
- Last updated
- 2019-02-25
- Results posted
- 2015-02-09
Locations
3 sites across 2 countries: Japan, Taiwan
Source: ClinicalTrials.gov record NCT01203098. Inclusion in this directory is not an endorsement.