Clinical trial NCT00306254: Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thrombosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-03-23
Enrollment: 1225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
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])
measure: The primary safety endpoint is the incidence of total bleeding.
Secondary outcomes:
measure: Secondary efficacy endpoints are incidence of proximal DVT, distal DVT, and PE.
measure: 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.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: North Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Encinitas
country: United States
facility: Pfizer Investigational Site
state: California
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Englewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Littleton
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Littleton
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Lone Tree
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Lone Tree
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Parker
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Coral Gables
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Flint
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Flint
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lubbock
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Caringbah
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Kogarah
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Bedford Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Daw Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Clayton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Dandenong
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: East Bentleigh
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: West Perth
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Guelph
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Weston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
state: Atlantico
city: Floridablanca
country: Colombia
facility: Pfizer Investigational Site
state: Santander
city: Cali
country: Colombia
facility: Pfizer Investigational Site
state: Valle
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Chomutov
country: Czech Republic
facility: Pfizer Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: Pfizer Investigational Site
city: Jihlava
country: Czech Republic
facility: Pfizer Investigational Site
city: Kladno
country: Czech Republic
facility: Pfizer Investigational Site
city: Pardubice
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 5
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 6
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
city: Trebic
country: Czech Republic
facility: Pfizer Investigational Site
city: Uherske Hradiste
country: Czech Republic
facility: Pfizer Investigational Site
city: Hellerup
country: Denmark
facility: Pfizer Investigational Site
city: Hoersholm
country: Denmark
facility: Pfizer Investigational Site
city: Hvidovre
country: Denmark
facility: Pfizer Investigational Site
city: Kjellerup
country: Denmark
facility: Pfizer Investigational Site
city: Kolding
country: Denmark
facility: Pfizer Investigational Site
city: Silkeborg
country: Denmark
facility: Pfizer Investigational Site
city: Viborg
country: Denmark
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Piacenza
country: Italy
facility: Pfizer Investigational Site
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Bytom
country: Poland
facility: Pfizer Investigational Site
city: Piekary Slaskie
country: Poland
facility: Pfizer Investigational Site
city: Sosnowiec
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Parede
country: Portugal
facility: Pfizer Investigational Site
city: Setúbal
country: Portugal
facility: Pfizer Investigational Site
city: Samara
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Alcorcon
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Mirasierra
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Epsom
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: