Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery
Phase 2
Completed
- Conditions
- Venous Thrombosis
- Registration Number
- NCT00306254
- Lead Sponsor
- Pfizer
- Brief Summary
To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin in preventing blood clots in the lungs or deep leg veins of patients after knee surgery
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1225
Inclusion Criteria
- Adult men or women scheduled for an elective, unilateral total knee replacement who are otherwise healthy.
Exclusion Criteria
- History of deep vein thrombosis or pulmonary embolism, suspected postthrombotic state, bleeding or clotting disorders, or cardiovascular, renal or liver disease within the past year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary safety endpoint is the incidence of total bleeding. The primary efficacy endpoint is the incidence of total venous thromboembolism (including all proximal and distal deep vein thrombosis [DVT] and pulmonary embolism [PE])
- Secondary Outcome Measures
Name Time Method Secondary efficacy endpoints are incidence of proximal DVT, distal DVT, and PE. Secondary safety endpoints are incidence of major and minor bleeding, all-cause mortality, abnormal liver function test elevation, adverse events and serious adverse events, and changes in clinical laboratory parameters.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧London, United Kingdom