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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00306254




Registration number
NCT00306254
Ethics application status
Date submitted
21/03/2006
Date registered
23/03/2006
Date last updated
10/10/2007

Titles & IDs
Public title
Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery
Scientific 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
Secondary ID [1] 0 0
A5571010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PD 0348292
Treatment: Drugs - Enoxaparin

Treatment: Drugs: PD 0348292


Treatment: Drugs: Enoxaparin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary efficacy endpoint is the incidence of total venous thromboembolism (including all proximal and distal deep vein thrombosis [DVT] and pulmonary embolism [PE])
Timepoint [1] 0 0
Primary outcome [2] 0 0
The primary safety endpoint is the incidence of total bleeding.
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Secondary efficacy endpoints are incidence of proximal DVT, distal DVT, and PE.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- Adult men or women scheduled for an elective, unilateral total knee replacement who
are otherwise healthy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Caringbah
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Kogarah
Recruitment hospital [3] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Bedford Park
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Daw Park
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Box Hill
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Dandenong
Recruitment hospital [9] 0 0
Pfizer Investigational Site - East Bentleigh
Recruitment hospital [10] 0 0
Pfizer Investigational Site - Nedlands
Recruitment hospital [11] 0 0
Pfizer Investigational Site - West Perth
Recruitment postcode(s) [1] 0 0
2229 - Caringbah
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
5041 - Daw Park
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3175 - Dandenong
Recruitment postcode(s) [9] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment postcode(s) [11] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
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California
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United States of America
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Colorado
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Florida
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Michigan
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New York
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Texas
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Canada
State/province [11] 0 0
Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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RM
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Colombia
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Antioquia
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Colombia
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Atlantico
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Colombia
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Santander
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Colombia
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Valle
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Czech Republic
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Brno
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Czech Republic
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Chomutov
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Czech Republic
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Hradec Kralove
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Czech Republic
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Jihlava
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Czech Republic
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Kladno
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Czech Republic
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Pardubice
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Czech Republic
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Praha 5
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Czech Republic
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Praha 6
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Czech Republic
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Praha 8
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Czech Republic
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Trebic
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Czech Republic
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Uherske Hradiste
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Denmark
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Hellerup
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Hoersholm
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Hvidovre
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Kjellerup
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Kolding
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Denmark
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Silkeborg
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Denmark
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Viborg
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France
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Nice
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France
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Paris
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Italy
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Bologna
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Italy
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Genova
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Italy
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Piacenza
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Poland
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Bialystok
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Bytom
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Piekary Slaskie
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Sosnowiec
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Warszawa
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Wroclaw
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Portugal
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Coimbra
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Portugal
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Parede
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Portugal
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Setúbal
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Yaroslavl
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Kosice
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Barcelona
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Surrey
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00306254
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00306254