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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00306254
Other study ID # A5571010
Secondary ID
Status Completed
Phase Phase 2
First received March 21, 2006
Last updated October 5, 2007
Start date March 2006
Est. completion date July 2007

Study information

Verified date October 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 1225
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
PD 0348292

Enoxaparin


Locations

Country Name City State
Australia Pfizer Investigational Site Bedford Park South Australia
Australia Pfizer Investigational Site Box Hill Victoria
Australia Pfizer Investigational Site Caringbah New South Wales
Australia Pfizer Investigational Site Clayton Victoria
Australia Pfizer Investigational Site Dandenong Victoria
Australia Pfizer Investigational Site Daw Park South Australia
Australia Pfizer Investigational Site East Bentleigh Victoria
Australia Pfizer Investigational Site Kogarah New South Wales
Australia Pfizer Investigational Site Nedlands Western Australia
Australia Pfizer Investigational Site St Leonards New South Wales
Australia Pfizer Investigational Site West Perth Western Australia
Canada Pfizer Investigational Site Guelph Ontario
Canada Pfizer Investigational Site Hamilton Ontario
Canada Pfizer Investigational Site Kelowna British Columbia
Canada Pfizer Investigational Site Kitchener Ontario
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Ottawa Ontario
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site Red Deer Alberta
Canada Pfizer Investigational Site Thunder Bay Ontario
Canada Pfizer Investigational Site Thunder Bay Ontario
Canada Pfizer Investigational Site Weston Ontario
Chile Pfizer Investigational Site Santiago RM
Colombia Pfizer Investigational Site Barranquilla Atlantico
Colombia Pfizer Investigational Site Cali Valle
Colombia Pfizer Investigational Site Floridablanca Santander
Colombia Pfizer Investigational Site Medellin Antioquia
Czech Republic Pfizer Investigational Site Brno
Czech Republic Pfizer Investigational Site Chomutov
Czech Republic Pfizer Investigational Site Hradec Kralove
Czech Republic Pfizer Investigational Site Jihlava
Czech Republic Pfizer Investigational Site Kladno
Czech Republic Pfizer Investigational Site Pardubice
Czech Republic Pfizer Investigational Site Praha 5
Czech Republic Pfizer Investigational Site Praha 6
Czech Republic Pfizer Investigational Site Praha 8
Czech Republic Pfizer Investigational Site Trebic
Czech Republic Pfizer Investigational Site Uherske Hradiste
Denmark Pfizer Investigational Site Hellerup
Denmark Pfizer Investigational Site Hoersholm
Denmark Pfizer Investigational Site Hvidovre
Denmark Pfizer Investigational Site Kjellerup
Denmark Pfizer Investigational Site Kolding
Denmark Pfizer Investigational Site Silkeborg
Denmark Pfizer Investigational Site Viborg
France Pfizer Investigational Site Nice
France Pfizer Investigational Site Paris
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Genova
Italy Pfizer Investigational Site Piacenza
Poland Pfizer Investigational Site Bialystok
Poland Pfizer Investigational Site Bytom
Poland Pfizer Investigational Site Piekary Slaskie
Poland Pfizer Investigational Site Sosnowiec
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Wroclaw
Portugal Pfizer Investigational Site Coimbra
Portugal Pfizer Investigational Site Parede
Portugal Pfizer Investigational Site Setúbal
Russian Federation Pfizer Investigational Site Samara
Russian Federation Pfizer Investigational Site St. Petersburg
Russian Federation Pfizer Investigational Site St. Petersburg
Russian Federation Pfizer Investigational Site Yaroslavl
Slovakia Pfizer Investigational Site Kosice
South Africa Pfizer Investigational Site Cape Town
South Africa Pfizer Investigational Site Johannesburg
South Africa Pfizer Investigational Site Johannesburg
Spain Pfizer Investigational Site Alcorcon Madrid
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Mirasierra Madrid
United Kingdom Pfizer Investigational Site Epsom Surrey
United Kingdom Pfizer Investigational Site London
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Coral Gables Florida
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Encinitas California
United States Pfizer Investigational Site Englewood Colorado
United States Pfizer Investigational Site Flint Michigan
United States Pfizer Investigational Site Flint Michigan
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Fountain Valley California
United States Pfizer Investigational Site Fountain Valley California
United States Pfizer Investigational Site Glendale California
United States Pfizer Investigational Site Hershey Pennsylvania
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site La Mesa California
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Littleton Colorado
United States Pfizer Investigational Site Littleton Colorado
United States Pfizer Investigational Site Lone Tree Colorado
United States Pfizer Investigational Site Lone Tree Colorado
United States Pfizer Investigational Site Long Beach California
United States Pfizer Investigational Site Long Beach California
United States Pfizer Investigational Site Long Beach California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Lubbock Texas
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site North Little Rock Arkansas
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Parker Colorado
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Santa Ana California
United States Pfizer Investigational Site St. Petersburg Florida
United States Pfizer Investigational Site St. Petersburg Florida
United States Pfizer Investigational Site St. Petersburg Florida
United States Pfizer Investigational Site St. Petersburg Florida
United States Pfizer Investigational Site Torrance California
United States Pfizer Investigational Site Winter Park Florida
United States Pfizer Investigational Site Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  Colombia,  Czech Republic,  Denmark,  France,  Italy,  Poland,  Portugal,  Russian Federation,  Slovakia,  South Africa,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary efficacy endpoint is the incidence of total venous thromboembolism (including all proximal and distal deep vein thrombosis [DVT] and pulmonary embolism [PE])
Primary The primary safety endpoint is the incidence of total bleeding.
Secondary Secondary efficacy endpoints are incidence of proximal DVT, distal DVT, and PE.
Secondary 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.
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