Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306254
Recruitment Status : Completed
First Posted : March 23, 2006
Last Update Posted : October 10, 2007
Information provided by:

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

Condition or disease Intervention/treatment Phase
Venous Thrombosis Drug: PD 0348292 Drug: Enoxaparin Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 1225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase 2B, Randomized, Multicenter, Dose-Ranging Study Assessing the Safety and Efficacy of PD 0348292 in the Prevention of Venous Thromboembolic Events (VTE) in Subjects Undergoing an Elective, Unilateral Total Knee Replacement
Study Start Date : March 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The primary efficacy endpoint is the incidence of total venous thromboembolism (including all proximal and distal deep vein thrombosis [DVT] and pulmonary embolism [PE])
  2. The primary safety endpoint is the incidence of total bleeding.

Secondary Outcome Measures :
  1. Secondary efficacy endpoints are incidence of proximal DVT, distal DVT, and PE.
  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306254

  Show 134 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information: Identifier: NCT00306254     History of Changes
Other Study ID Numbers: A5571010
First Posted: March 23, 2006    Key Record Dates
Last Update Posted: October 10, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action