Phase 3
Completed N=716
A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
Source: ClinicalTrials.gov NCT01181102 ↗Enrolled (actual)
716
Serious AEs
3.0%
Results posted
Feb 2015
Primary outcomePrimary: Incidence of Subjects With Venous Thromboembolism Events. — 7.4; 13.9 percent of participants with VTE events — p=<0.001
Summary
The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Subjects With Venous Thromboembolism Events. |
7.4; 13.9 | <0.001 sig |
| SECONDARY Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. |
6.2; 3.7 | — |
Eligibility Criteria
Inclusion Criteria
- Patients undergoing unilateral total knee arthroplasty
Exclusion Criteria
- Subjects with risks of hemorrhage
- Subjects with thromboembolic risks
- Subjects who weigh less than 40 kg
- Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.
Data sourced from ClinicalTrials.gov (NCT01181102). 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. Informational only — not medical advice.