Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement



Status:Completed
Conditions:Cardiology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:January 2005
End Date:December 2005

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase IIa, Multi-center, Multi-national, Open Label, Dose Ranging Study of the Efficacy, Safety, and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty

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.

The primary study objective is to demonstrate prevention of venous thromboembolism in
patients undergoing total hip replacement surgery. The secondary objective is to assess the
safety and tolerability of DU-176.

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
We found this trial at
1
site
Local Institution
2675 North Decatur Road
Decatur, Georgia 30033
?
mi
from
Decatur, GA
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