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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: March 21, 2006
Last updated: October 5, 2007
Last verified: October 2007
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 Intervention Phase
Venous Thrombosis
Drug: PD 0348292
Drug: Enoxaparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 1225
Study Start Date: March 2006
Study Completion Date: July 2007

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00306254

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Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00306254     History of Changes
Other Study ID Numbers: A5571010 
Study First Received: March 21, 2006
Last Updated: October 5, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on May 25, 2016