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

Primary Purpose

Venous Thrombosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PD 0348292
Enoxaparin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
March 21, 2006
Last Updated
October 5, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00306254
Brief Title
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

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1225 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PD 0348292
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Primary Outcome Measure Information:
Title
The primary efficacy endpoint is the incidence of total venous thromboembolism (including all proximal and distal deep vein thrombosis [DVT] and pulmonary embolism [PE])
Title
The primary safety endpoint is the incidence of total bleeding.
Secondary Outcome Measure Information:
Title
Secondary efficacy endpoints are incidence of proximal DVT, distal DVT, and PE.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Pfizer Investigational Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72118
Country
United States
Facility Name
Pfizer Investigational Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Pfizer Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-4004
Country
United States
Facility Name
Pfizer Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Pfizer Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Pfizer Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pfizer Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Pfizer Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pfizer Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Pfizer Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80011
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80013
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Pfizer Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Pfizer Investigational Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Pfizer Investigational Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80123
Country
United States
Facility Name
Pfizer Investigational Site
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80123
Country
United States
Facility Name
Pfizer Investigational Site
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Pfizer Investigational Site
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Pfizer Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Pfizer Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Pfizer Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Pfizer Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Pfizer Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Pfizer Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Pfizer Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Pfizer Investigational Site
City
Caringbah
State/Province
New South Wales
ZIP/Postal Code
2229
Country
Australia
Facility Name
Pfizer Investigational Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Pfizer Investigational Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Pfizer Investigational Site
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Pfizer Investigational Site
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Pfizer Investigational Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Pfizer Investigational Site
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Pfizer Investigational Site
City
Dandenong
State/Province
Victoria
ZIP/Postal Code
3175
Country
Australia
Facility Name
Pfizer Investigational Site
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Pfizer Investigational Site
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Facility Name
Pfizer Investigational Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 4E7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1T2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1E 4J4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 7C7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Santiago
State/Province
RM
ZIP/Postal Code
8380419
Country
Chile
Facility Name
Pfizer Investigational Site
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Floridablanca
State/Province
Santander
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Cali
State/Province
Valle
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
663 50
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Chomutov
ZIP/Postal Code
430 12
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Jihlava
ZIP/Postal Code
586 33
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Kladno
ZIP/Postal Code
272 59
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 6
ZIP/Postal Code
169 02
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 8
ZIP/Postal Code
180 81
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Trebic
ZIP/Postal Code
674 01
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Uherske Hradiste
ZIP/Postal Code
686 68
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Hoersholm
ZIP/Postal Code
2970
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Kjellerup
ZIP/Postal Code
8620
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Silkeborg
ZIP/Postal Code
8700
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bialystok
Country
Poland
Facility Name
Pfizer Investigational Site
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Pfizer Investigational Site
City
Piekary Slaskie
ZIP/Postal Code
41-940
Country
Poland
Facility Name
Pfizer Investigational Site
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
ZIP/Postal Code
50-043
Country
Poland
Facility Name
Pfizer Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Parede
ZIP/Postal Code
2779-502
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Setúbal
ZIP/Postal Code
2900-182
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
195427
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Cape Town
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Pfizer Investigational Site
City
Mirasierra
State/Province
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Epsom
State/Province
Surrey
ZIP/Postal Code
KT18 7EG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE5 9PJ
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5571010&StudyName=Evaluation%20of%20PD%200348292%20for%20preventing%20blood%20clots%20in%20the%20lungs%20or%20deep%20leg%20veins%20of%20patients%20after%20knee%20surgery
Description
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Learn more about this trial

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

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