drugset / Trial / NCT01203072
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2006-07
- Primary completion
- 2007-09
- Completion
- 2008-07
Outcome
Met primary endpoint
registry NUMBER DU-176b 60 mg: 9.1 (3.1 to 15.1) percentage of participants NUMBER Placebo: 48.3 (37.9 to 58.7) percentage of participants NCT01203072 ↗
registry analysis (superiority or other test); DU-176b 5 mg vs DU-176b 15 mg vs DU-176b 30 mg vs DU-176b 60 mg vs Placebo; p <0.001; Cochran-Armitage NCT01203072 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Edoxaban | Small molecule | 5 mg | Oral |
| Subject | Edoxaban | Small molecule | 15 mg | Oral |
| Subject | Edoxaban | Small molecule | 30 mg | Oral |
| Subject | Edoxaban | Small molecule | 60 mg | Oral |