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

October 5, 2007 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Venous Thrombosis

Intervention / Treatment

Study Type

Interventional

Enrollment

1225

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Caringbah, New South Wales, Australia, 2229
    - Pfizer Investigational Site
  - Kogarah, New South Wales, Australia, 2217
    - Pfizer Investigational Site
  - St Leonards, New South Wales, Australia, 2065
    - Pfizer Investigational Site
- South Australia
  - Bedford Park, South Australia, Australia, 5042
    - Pfizer Investigational Site
  - Daw Park, South Australia, Australia, 5041
    - Pfizer Investigational Site
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Pfizer Investigational Site
  - Clayton, Victoria, Australia, 3168
    - Pfizer Investigational Site
  - Dandenong, Victoria, Australia, 3175
    - Pfizer Investigational Site
  - East Bentleigh, Victoria, Australia, 3165
    - Pfizer Investigational Site
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Pfizer Investigational Site
  - West Perth, Western Australia, Australia, 6005
    - Pfizer Investigational Site
Canada
- - Quebec, Canada, G1J 1Z4
    - Pfizer Investigational Site
- Alberta
  - Red Deer, Alberta, Canada, T4N 4E7
    - Pfizer Investigational Site
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 1T2
    - Pfizer Investigational Site
- Ontario
  - Guelph, Ontario, Canada, N1E 4J4
    - Pfizer Investigational Site
  - Hamilton, Ontario, Canada, L8N 4A6
    - Pfizer Investigational Site
  - Kitchener, Ontario, Canada, N2G 1G3
    - Pfizer Investigational Site
  - Ottawa, Ontario, Canada, K1H 8L6
    - Pfizer Investigational Site
  - Thunder Bay, Ontario, Canada, P7B 6V4
    - Pfizer Investigational Site
  - Thunder Bay, Ontario, Canada, P7B 7C7
    - Pfizer Investigational Site
  - Weston, Ontario, Canada, M9N 1N8
    - Pfizer Investigational Site
- Quebec
  - Montreal, Quebec, Canada, H1T 2M4
    - Pfizer Investigational Site
Chile
- RM
  - Santiago, RM, Chile, 8380419
    - Pfizer Investigational Site
Colombia
- Antioquia
  - Medellin, Antioquia, Colombia
    - Pfizer Investigational Site
- Atlantico
  - Barranquilla, Atlantico, Colombia
    - Pfizer Investigational Site
- Santander
  - Floridablanca, Santander, Colombia
    - Pfizer Investigational Site
- Valle
  - Cali, Valle, Colombia
    - Pfizer Investigational Site
Czech Republic
- - Brno, Czech Republic, 663 50
    - Pfizer Investigational Site
  - Chomutov, Czech Republic, 430 12
    - Pfizer Investigational Site
  - Hradec Kralove, Czech Republic, 500 05
    - Pfizer Investigational Site
  - Jihlava, Czech Republic, 586 33
    - Pfizer Investigational Site
  - Kladno, Czech Republic, 272 59
    - Pfizer Investigational Site
  - Pardubice, Czech Republic, 532 03
    - Pfizer Investigational Site
  - Praha 5, Czech Republic, 150 06
    - Pfizer Investigational Site
  - Praha 6, Czech Republic, 169 02
    - Pfizer Investigational Site
  - Praha 8, Czech Republic, 180 81
    - Pfizer Investigational Site
  - Trebic, Czech Republic, 674 01
    - Pfizer Investigational Site
  - Uherske Hradiste, Czech Republic, 686 68
    - Pfizer Investigational Site
Denmark
- - Hellerup, Denmark, 2900
    - Pfizer Investigational Site
  - Hoersholm, Denmark, 2970
    - Pfizer Investigational Site
  - Hvidovre, Denmark, 2650
    - Pfizer Investigational Site
  - Kjellerup, Denmark, 8620
    - Pfizer Investigational Site
  - Kolding, Denmark, 6000
    - Pfizer Investigational Site
  - Silkeborg, Denmark, 8700
    - Pfizer Investigational Site
  - Viborg, Denmark, 8800
    - Pfizer Investigational Site
France
- - Nice, France, 06200
    - Pfizer Investigational Site
  - Paris, France, 75013
    - Pfizer Investigational Site
Italy
- - Bologna, Italy, 40136
    - Pfizer Investigational Site
  - Genova, Italy, 16132
    - Pfizer Investigational Site
  - Piacenza, Italy, 29100
    - Pfizer Investigational Site
Poland
- - Bialystok, Poland
    - Pfizer Investigational Site
  - Bytom, Poland, 41-902
    - Pfizer Investigational Site
  - Piekary Slaskie, Poland, 41-940
    - Pfizer Investigational Site
  - Sosnowiec, Poland, 41-200
    - Pfizer Investigational Site
  - Warszawa, Poland, 00-909
    - Pfizer Investigational Site
  - Warszawa, Poland, 03-242
    - Pfizer Investigational Site
  - Wroclaw, Poland, 50-043
    - Pfizer Investigational Site
Portugal
- - Coimbra, Portugal, 3000-075
    - Pfizer Investigational Site
  - Parede, Portugal, 2779-502
    - Pfizer Investigational Site
  - Setúbal, Portugal, 2900-182
    - Pfizer Investigational Site
Russian Federation
- - Samara, Russian Federation, 443095
    - Pfizer Investigational Site
  - St. Petersburg, Russian Federation, 193312
    - Pfizer Investigational Site
  - St. Petersburg, Russian Federation, 195427
    - Pfizer Investigational Site
  - Yaroslavl, Russian Federation, 150003
    - Pfizer Investigational Site
Slovakia
- - Kosice, Slovakia, 04011
    - Pfizer Investigational Site
South Africa
- - Cape Town, South Africa, 7405
    - Pfizer Investigational Site
  - Johannesburg, South Africa, 2193
    - Pfizer Investigational Site
  - Johannesburg, South Africa, 2013
    - Pfizer Investigational Site
Spain
- - Barcelona, Spain, 08035
    - Pfizer Investigational Site
  - Barcelona, Spain, 08036
    - Pfizer Investigational Site
  - Barcelona, Spain, 08024
    - Pfizer Investigational Site
  - Madrid, Spain, 28040
    - Pfizer Investigational Site
- Madrid
  - Alcorcon, Madrid, Spain, 28922
    - Pfizer Investigational Site
  - Mirasierra, Madrid, Spain, 28034
    - Pfizer Investigational Site
United Kingdom
- - London, United Kingdom, SE5 9PJ
    - Pfizer Investigational Site
- Surrey
  - Epsom, Surrey, United Kingdom, KT18 7EG
    - Pfizer Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Pfizer Investigational Site
  - Birmingham, Alabama, United States, 35205
    - Pfizer Investigational Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Pfizer Investigational Site
  - North Little Rock, Arkansas, United States, 72118
    - Pfizer Investigational Site
- California
  - Encinitas, California, United States, 92024
    - Pfizer Investigational Site
  - Fountain Valley, California, United States, 92708
    - Pfizer Investigational Site
  - Fountain Valley, California, United States, 92708-4004
    - Pfizer Investigational Site
  - Glendale, California, United States, 91206
    - Pfizer Investigational Site
  - La Mesa, California, United States, 91942
    - Pfizer Investigational Site
  - Long Beach, California, United States, 90806
    - Pfizer Investigational Site
  - Long Beach, California, United States, 90813
    - Pfizer Investigational Site
  - Long Beach, California, United States, 92708
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90048
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90045
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90036
    - Pfizer Investigational Site
  - Santa Ana, California, United States, 92704
    - Pfizer Investigational Site
  - Torrance, California, United States, 90509
    - Pfizer Investigational Site
- Colorado
  - Aurora, Colorado, United States, 80012
    - Pfizer Investigational Site
  - Aurora, Colorado, United States, 80011
    - Pfizer Investigational Site
  - Aurora, Colorado, United States, 80013
    - Pfizer Investigational Site
  - Denver, Colorado, United States, 80230
    - Pfizer Investigational Site
  - Englewood, Colorado, United States, 80110
    - Pfizer Investigational Site
  - Littleton, Colorado, United States, 80122
    - Pfizer Investigational Site
  - Littleton, Colorado, United States, 80123
    - Pfizer Investigational Site
  - Lone Tree, Colorado, United States, 80124
    - Pfizer Investigational Site
  - Lone Tree, Colorado, United States, 80123
    - Pfizer Investigational Site
  - Parker, Colorado, United States, 80138
    - Pfizer Investigational Site
- Florida
  - Coral Gables, Florida, United States, 33134
    - Pfizer Investigational Site
  - Hollywood, Florida, United States, 33021
    - Pfizer Investigational Site
  - Miami, Florida, United States, 33136
    - Pfizer Investigational Site
  - Miami, Florida, United States, 33125
    - Pfizer Investigational Site
  - Miami, Florida, United States, 33186
    - Pfizer Investigational Site
  - Miami, Florida, United States, 33175
    - Pfizer Investigational Site
  - Orlando, Florida, United States, 32804
    - Pfizer Investigational Site
  - St. Petersburg, Florida, United States, 33703
    - Pfizer Investigational Site
  - St. Petersburg, Florida, United States, 33707
    - Pfizer Investigational Site
  - St. Petersburg, Florida, United States, 33701
    - Pfizer Investigational Site
  - St. Petersburg, Florida, United States, 33705
    - Pfizer Investigational Site
  - Winter Park, Florida, United States, 32789
    - Pfizer Investigational Site
  - Winter Park, Florida, United States, 32792
    - Pfizer Investigational Site
- Michigan
  - Flint, Michigan, United States, 48507
    - Pfizer Investigational Site
  - Flint, Michigan, United States, 48503
    - Pfizer Investigational Site
- New York
  - Rochester, New York, United States, 14620
    - Pfizer Investigational Site
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Pfizer Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29414
    - Pfizer Investigational Site
  - Charleston, South Carolina, United States, 29401
    - Pfizer Investigational Site
- Texas
  - Dallas, Texas, United States, 75231
    - Pfizer Investigational Site
  - Fort Worth, Texas, United States, 76104
    - Pfizer Investigational Site
  - Fort Worth, Texas, United States, 76107
    - Pfizer Investigational Site
  - Houston, Texas, United States, 77030
    - Pfizer Investigational Site
  - Houston, Texas, United States, 77024
    - Pfizer Investigational Site
  - Houston, Texas, United States, 77025
    - Pfizer Investigational Site
  - Lubbock, Texas, United States, 79410
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78229
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78217
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78258
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78240
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78233
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

March 21, 2006

First Submitted That Met QC Criteria

March 21, 2006

First Posted (Estimate)

March 23, 2006

Study Record Updates

Last Update Posted (Estimate)

October 10, 2007

Last Update Submitted That Met QC Criteria

October 5, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A5571010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.