Status:
COMPLETED
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Lead Sponsor:
Daiichi Sankyo
Conditions:
Arthroplasty, Replacement, Hip
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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,...
Detailed Description
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 tolerabilit...
Eligibility Criteria
Inclusion
- Unilateral hip replacement
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
606 Patients enrolled
Trial Details
Trial ID
NCT00107900
Start Date
January 1 2005
End Date
December 1 2005
Last Update
February 26 2019
Active Locations (1)
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1
Local Institution
Decatur, Georgia, United States, 30033