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

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NCT00306254

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thrombosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adult men or women scheduled for an elective, unilateral total knee replacement who are otherwise healthy.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Venous ThrombosisEvaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery NCT00306254
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Little Rock, Arkansas
  4. North Little Rock, Arkansas
  5. Encinitas, California
  6. Fountain Valley, California
  7. Fountain Valley, California
  8. Glendale, California
  9. La Mesa, California
  10. Long Beach, California
  11. Long Beach, California
  12. Long Beach, California
  13. Los Angeles, California
  14. Los Angeles, California
  15. Los Angeles, California
  16. Santa Ana, California
  17. Torrance, California
  18. Aurora, Colorado
  19. Aurora, Colorado
  20. Aurora, Colorado
  21. Denver, Colorado
  22. Englewood, Colorado
  23. Littleton, Colorado
  24. Littleton, Colorado
  25. Lone Tree, Colorado
  26. Lone Tree, Colorado
  27. Parker, Colorado
  28. Coral Gables, Florida
  29. Hollywood, Florida
  30. Miami, Florida
  31. Miami, Florida
  32. Miami, Florida
  33. Miami, Florida
  34. Orlando, Florida
  35. St. Petersburg, Florida
  36. St. Petersburg, Florida
  37. St. Petersburg, Florida
  38. St. Petersburg, Florida
  39. Winter Park, Florida
  40. Winter Park, Florida
  41. Flint, Michigan
  42. Flint, Michigan
  43. Rochester, New York
  44. Hershey, Pennsylvania
  45. Charleston, South Carolina
  46. Charleston, South Carolina
  47. Dallas, Texas
  48. Fort Worth, Texas
  49. Fort Worth, Texas
  50. Houston, Texas
  51. Houston, Texas
  52. Houston, Texas
  53. Lubbock, Texas
  54. San Antonio, Texas
  55. San Antonio, Texas
  56. San Antonio, Texas
  57. San Antonio, Texas
  58. San Antonio, Texas
  59. Caringbah, New South Wales
  60. Kogarah, New South Wales
  61. St Leonards, New South Wales
  62. Bedford Park, South Australia
  63. Daw Park, South Australia
  64. Box Hill, Victoria
  65. Clayton, Victoria
  66. Dandenong, Victoria
  67. East Bentleigh, Victoria
  68. Nedlands, Western Australia
  69. West Perth, Western Australia
  70. Red Deer, Alberta
  71. Kelowna, British Columbia
  72. Guelph, Ontario
  73. Hamilton, Ontario
  74. Kitchener, Ontario
  75. Ottawa, Ontario
  76. Thunder Bay, Ontario
  77. Thunder Bay, Ontario
  78. Weston, Ontario
  79. Montreal, Quebec
  80. Quebec,
  81. Santiago, RM
  82. Medellin, Antioquia
  83. Barranquilla, Atlantico
  84. Floridablanca, Santander
  85. Cali, Valle
  86. Brno,
  87. Chomutov,
  88. Hradec Kralove,
  89. Jihlava,
  90. Kladno,
  91. Pardubice,
  92. Praha 5,
  93. Praha 6,
  94. Praha 8,
  95. Trebic,
  96. Uherske Hradiste,
  97. Hellerup,
  98. Hoersholm,
  99. Hvidovre,
  100. Kjellerup,
  101. Kolding,
  102. Silkeborg,
  103. Viborg,
  104. Nice,
  105. Paris,
  106. Bologna,
  107. Genova,
  108. Piacenza,
  109. Bialystok,
  110. Bytom,
  111. Piekary Slaskie,
  112. Sosnowiec,
  113. Warszawa,
  114. Warszawa,
  115. Wroclaw,
  116. Coimbra,
  117. Parede,
  118. Setúbal,
  119. Samara,
  120. St. Petersburg,
  121. St. Petersburg,
  122. Yaroslavl,
  123. Kosice,
  124. Cape Town,
  125. Johannesburg,
  126. Johannesburg,
  127. Alcorcon, Madrid
  128. Mirasierra, Madrid
  129. Barcelona,
  130. Barcelona,
  131. Barcelona,
  132. Madrid,
  133. Epsom, Surrey
  134. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Venous Thrombosis
Intervention  ICMJE
  • Drug: PD 0348292
  • Drug: Enoxaparin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 21, 2006)		1225
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   France,   Italy,   Poland,   Portugal,   Russian Federation,   Slovakia,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00306254
Other Study ID Numbers  ICMJE A5571010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP