Phase 3
Completed N=610
A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Prevention · Venous Thromboembolism
Source: ClinicalTrials.gov NCT01181167 ↗
Enrolled (actual)
610
Serious AEs
3.0%
Results posted
Jan 2015
Primary outcomePrimary: Incidence of Subjects With Venous Thromboembolism Events — 2.4; 6.9 percentage of subjects 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 hip arthroplasty.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Subjects With Venous Thromboembolism Events |
2.4; 6.9 | <0.001 sig |
| SECONDARY Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding |
2.6; 3.7 | — |
Eligibility Criteria
Inclusion Criteria
- Patients undergoing unilateral total hip 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 (NCT01181167). 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.