Venous Thrombosis Clinical Trial
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
| Verified date | October 2007 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Canada, Chile, Colombia, Czech Republic, Denmark, France, Italy, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, United Kingdom,
| 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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