A Clinical Trial Comparing Torcetrapib/Atorvastatin to Ezetimibe/Simvastatin In Subjects With A Cholesterol Disorder.

NCT00267267

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209-7802, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hyperlipidemia, Dyslipidemia
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

- Specific LDL-C levels based on CHD risk after a six-week washout period.

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


- Women who are pregnant or lactating, or planning to become pregnant.


- Subjects taking any drugs known to be associated with an increased risk of myositis in
combination with HMG-CoA reductase inhibitors.


- Subjects requiring systemic steroids


- Subjects with any other medical condition or laboratory abnormality which could affect
subject safety, preclude evaluation of response, or render unlikely that the subject
would complete the study.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Hyperlipidemia, DyslipidemiaA Clinical Trial Comparing Torcetrapib/Atorvastatin to Ezetimibe/Simvastatin In Subjects With A Cholesterol Disorder.
NCT00267267
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Chandler, Arizona
  4. Mesa, Arizona
  5. Jonesboro, Arkansas
  6. Anaheim, California
  7. Escondido, California
  8. Fresno, California
  9. Los Altos, California
  10. Los Angeles, California
  11. Palm Springs, California
  12. Paramount, California
  13. San Diego, California
  14. Santa Rose, California
  15. Walnut Creek, California
  16. Westlake Village, California
  17. Golden, Colorado
  18. New Haven, Connecticut
  19. Newark, Delaware
  20. Washington, District of Columbia
  21. Atlantis, Florida
  22. Boca Raton, Florida
  23. Daytona Beach, Florida
  24. DeFuniak Springs, Florida
  25. Destin, Florida
  26. Lakeland, Florida
  27. Miami, Florida
  28. Miami, Florida
  29. Miami, Florida
  30. Orlando, Florida
  31. Pensacola, Florida
  32. Atlanta, Georgia
  33. Atlanta, Georgia
  34. Atlanta, Georgia
  35. Honolulu, Hawaii
  36. Aurora, Illinois
  37. Chicago, Illinois
  38. Rockford, Illinois
  39. Springfield, Illinois
  40. Evansville, Indiana
  41. Evansville, Indiana
  42. Evansville, Indiana
  43. Des Moines, Iowa
  44. Newton, Kansas
  45. Overland Park, Kansas
  46. Pratt, Kansas
  47. Topeka, Kansas
  48. Edgewood, Kentucky
  49. Erlanger, Kentucky
  50. Louisville, Kentucky
  51. Columbia, Maryland
  52. Ayer, Massachusetts
  53. Boston, Massachusetts
  54. Boston, Massachusetts
  55. Milford, Massachusetts
  56. Bloomfield Hills, Michigan
  57. Grand Rapids, Michigan
  58. Troy, Michigan
  59. Brooklyn Center, Minnesota
  60. Edina, Minnesota
  61. St. Cloud, Minnesota
  62. Columbia, Missouri
  63. Jefferson City, Missouri
  64. Manchester, Missouri
  65. Springfield, Missouri
  66. Springfield, Missouri
  67. Omaha, Nebraska
  68. Omaha, Nebraska
  69. Omaha, Nebraska
  70. Las Vegas, Nevada
  71. Las Vegas, Nevada
  72. Cooperstown, New York
  73. Endwell, New York
  74. Lewiston, New York
  75. Manlius, New York
  76. Rochester, New York
  77. Rochester, New York
  78. Syracuse, New York
  79. West Seneca, New York
  80. Cary, North Carolina
  81. Charlotte, North Carolina
  82. Huntersville, North Carolina
  83. Monroe, North Carolina
  84. Raleigh, North Carolina
  85. Wilmington, North Carolina
  86. Winston-Salem, North Carolina
  87. Winston-Salem, North Carolina
  88. Cincinnati, Ohio
  89. Cleveland, Ohio
  90. Fairview Park, Ohio
  91. Beaver, Pennsylvania
  92. Bensalem, Pennsylvania
  93. Doylestown, Pennsylvania
  94. Harleysville, Pennsylvania
  95. Lancaster, Pennsylvania
  96. Pittsburgh, Pennsylvania
  97. Pittsburgh, Pennsylvania
  98. Sayre, Pennsylvania
  99. Lincoln, Rhode Island
  100. Providence, Rhode Island
  101. Anderson, South Carolina
  102. Mount Pleasant, South Carolina
  103. Simpsonville, South Carolina
  104. Bristol, Tennessee
  105. Chattanooga, Tennessee
  106. Germantown, Tennessee
  107. Johnson City, Tennessee
  108. Memphis, Tennessee
  109. Memphis, Tennessee
  110. Memphis, Tennessee
  111. Memphis, Tennessee
  112. Selmer, Tennessee
  113. Arlington, Texas
  114. Houston, Texas
  115. Houston, Texas
  116. San Antonio, Texas
  117. San Antonio, Texas
  118. Bountiful, Utah
  119. Salt Lake City, Utah
  120. Newport News, Virginia
  121. Norfolk, Virginia
  122. Renton, Washington
  123. Spokane, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Clinical Trial Comparing Torcetrapib/Atorvastatin to Ezetimibe/Simvastatin In Subjects With A Cholesterol Disorder.
Official Title  ICMJE Phase 3, Open-Label, Multi-Center, Double-Blind, Randomized, Parallel Group Study Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin, Administered Once Daily (QD) Compared to Fixed Combination Ezetimibe/Simvastatin for 6 Weeks in Subjects With Dyslipidemia.
Brief Summary

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of combination cholesterol medications to see how the different treatments compare to one another.

Detailed Description For additional information please call: 1-800-718-1021
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperlipidemia
  • Dyslipidemia
Intervention  ICMJE
  • Drug: torcetrapib/atorvastatin
  • Drug: ezetimibe/simvastatin
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 Terminated
Enrollment  ICMJE
 (submitted: December 19, 2005)
1784
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Specific LDL-C levels based on CHD risk after a six-week washout period.

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
  • Subjects requiring systemic steroids
  • Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00267267
Other Study ID Numbers  ICMJE A5091035
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 December 2006

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