Phase 2
Completed N=896
A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
Source: ClinicalTrials.gov NCT00398216 ↗Enrolled (actual)
896
Serious AEs
3.9%
Results posted
Feb 2015
Primary outcomePrimary: Adjudicated Incidence of VTE — 29.0; 20.3; 15.7; 11.5 percentage of participants with VTE — p=0.003
Summary
This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjudicated Incidence of VTE |
29.0; 20.3; 15.7; 11.5; 46.0 | 0.003 sig |
| SECONDARY Change in Prothrombin Time (PT) From Baseline |
.90; 1.07; 2.87; 2.74; .67 | — |
| SECONDARY Change in Activated Partial Thromboplastin Time (aPTT) From Baseline |
-0.33; 1.67; 4.39; 3.26; 2.34 | — |
| SECONDARY Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events |
1.6; 1.8; 2.2; 2.3; 0 | .250 |
Eligibility Criteria
- 18 years of age or older; male or female.
- Able to provide written informed consent.
- Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted.
- If female, must be either one year post-menopausal, surgically sterile, or using medically accepted contraceptive measures as judged by the Investigator and in accordance with local regulatory requirements.
Data sourced from ClinicalTrials.gov (NCT00398216). 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.