Dose Ranging Study in Elective Total Hip Replacement Surgery

A Multicenter, Randomized, Double-Blind, Double Dummy, Parallel Group, Dose Ranging Study of Subcutaneous SR123781A With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery

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 replacement surgery.

The secondary objectives are to:

• evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery; and
• to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery.

Inclusion Criteria:

• 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 Criteria:

• 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