Phase 2
N=523
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
Venous Thromboembolism · Deep Vein Thrombosis · Total Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT01203072 ↗Enrolled (actual)
523
Serious AEs
2.3%
Results posted
Jan 2015
Primary outcome: Primary: Proportion of Subjects With Venous Thromboembolism Events. — 29.5; 26.1; 12.5; 9.1 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DU-176b (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Venous Thromboembolism Events. |
29.5; 26.1; 12.5; 9.1; 48.3 | <0.001 sig |
| SECONDARY Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding |
1.9; 3.8; 3.9; 4.7; 3.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing unilateral total knee arthroplasty
Exclusion Criteria
- risks of hemorrhage
- thromboembolic risks
- weight less than 40 kg
- pregnant, suspect pregnancy, or subjects who want to become pregnant
Data sourced from ClinicalTrials.gov (NCT01203072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.