DVT Prophylaxis in Total Knee Replacement Trial

A Phase 2B, randomized, multicenter, dose-ranging study assessing the safety and efficacy of PD0348292 in the prevention of Venous Thromboembolism Events (VTE) in subjects undergoing an elective, unilateral total knee replacement.

Principal Investigator:
Paul C. Peter, Jr., M.D.

Sub-investigators:
Michael Champine, M.D.
William Tucker, M.D.
Michael Katz, M.D.

This clinical trial studies the effectiveness and safety of a new oral medication (PD 0348292) for the prevention of Deep Vein Thrombosis (DVT) in patients undergoing elective total knee replacement. It is being compared to an FDA approved medication (enoxaparin sodium) to treat and prevent DVT. PD 0348292 is not an FDA approved medication but is being studied to become approved.

Eligibility Criteria (this is not a comprehensive list)

Inclusion Criteria

• Male and female patients aged 18 years or above
• Patients scheduled for elective, unilateral, total knee replacement
• Agreeable to comply with scheduled visits, laboratory tests, treatment plan, and other study procedures

Exclusion Criteria

• Planned, staged total bilateral knee replacement
• Females under 99 lbs and males under 125 lbs
• Pregnant or lactating women; women who plan to become pregnant
• History of DVT
• Positive urine test for blood in urine; positive for protein in urine
• Uncontrolled hypertension (high blood pressure that is not controlled with medication)
• Lab results indicating anemia
• Coagulation (blood does not clot) disorders
• Severe Renal (kidney) dysfunction
• Active hepatic (liver) disease, or hepatic insufficiency
• Drug or alcohol abuse Active malignancy (cancer)
• Considered immunocompromised (AIDS, HIV)
• An ischemic stroke or myocardial infarction within the last three months
• Surgery/trauma within the last 6 months; laparoscopic surgery within the last 6 weeks
• Immobilized
• An increased risk of bleeding
• Problems with drug absorption
• Requiring ongoing anticoagulation treatment that can not (safely) be stopped
• History of adverse reaction to blood thinner medications
• Allergy to contrast media or iodine
• Clinically significant ECG findings
• Previous participation in the study of this drug
• Therapy with another investigational product within 30 days prior start of study