Phase 3
Completed N=92
Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery
Source: ClinicalTrials.gov NCT01181141 ↗Enrolled (actual)
92
Serious AEs
6.8%
Results posted
Jan 2015
Primary outcomePrimary: The Incidence of Major or Clinically Relevant Non-major Bleeding — 3.4; 6.9 percentage of subjects with bleeds
Summary
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Major or Clinically Relevant Non-major Bleeding |
3.4; 6.9 | — |
| SECONDARY Proportion of Subjects With Venous Thromboembolism Events. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)
Exclusion Criteria
- Subjects with risks of hemorrhage
- Subjects with thrombolic 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 (NCT01181141). 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.