Status:
COMPLETED
Dose Ranging Study in Elective Total Hip Replacement Surgery
Lead Sponsor:
Sanofi
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The primary objective is to: * demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE) by the demonstration of a dose-response in patients undergoing total hip replace...
Eligibility Criteria
Inclusion
- Patients scheduled to undergo elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed \> 6 months prior to study entry
Exclusion
- Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization
- Known progressive malignant disease
- Ischemic stroke in the last 3 months
- Myocardial infarction (MI) in the last 3 months
- Any major orthopedic surgery in the 3 months prior to study start
- Clinical signs or symptoms of DVT or PE within the last 12 months or symptoms of post phlebitic syndrome (these conditions may confound DVT/PE assessments)
- Treatment with other antithrombotic agents within 7 days prior to surgery
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
1090 Patients enrolled
Trial Details
Trial ID
NCT00338897
Start Date
May 1 2006
End Date
May 1 2007
Last Update
December 10 2008
Active Locations (14)
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1
Sanofi-Aventis
San Isidro, Buenos Aires, Argentina, 1642
2
Sanofi-Aventis
Sofia, Bulgaria, 1715
3
Sanofi-Aventis
Providencia, Santiago Metropolitan, Chile
4
Sanofi-Aventis
Bogotá, Colombia