Phase 2
N=606
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Arthroplasty, Replacement, Hip · Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT00107900 ↗Enrolled (actual)
606
Serious AEs
6.6%
Results posted
Mar 2015
Primary outcome: Primary: Prevention of Venous Thromboembolism (VTE) — 13; 13; 10; 13 percentage of patients with event — p=0.238
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DU-176b (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- Dec 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevention of Venous Thromboembolism (VTE) |
13; 13; 10; 13; 16; 17 | 0.238 |
| SECONDARY Change From Baseline for Prothrombin Time (PT) Results |
-.2; -.1; .7; .8; 1.1; 1.8 | — |
| SECONDARY Change From Baseline for International Normalized Ratio (INR) Results |
0; 0; .1; .1; .1; .2 | — |
| SECONDARY Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results |
-5.1; -1.6; 2.5; 4.1; 5.8; 11.3 | — |
Summary
Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.
Eligibility Criteria
Inclusion Criteria
- Unilateral hip replacement
Exclusion Criteria
- Patients scheduled for bilateral hip replacement in same procedure
- Patients with increased risk of bleeding
- Uncontrolled hypertension (BP greater than 180/100 mmHg)
- Patients less than 111 lbs or more than 243 lbs
- Patients on long-term anticoagulants
- Patients with contraindications to venography
- Patients with medical history of venous thromboembolism
- Patients with impaired hepatic function
- Known to be pregnant
- Lactating women
Data sourced from ClinicalTrials.gov (NCT00107900). 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.