A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease

NCT00134173

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, , 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]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Coronary Disease, Coronary Arteriosclerosis, Hyperlipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- angiographic evidence of coronary atherosclerosis

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 with a clinically indicated need for statin (HMG-CoA reductase inhibitor)
therapy other than atorvastatin or other concomitant therapy with known lipid altering
effects on LDL-C and HDL-C including fibrates and nicotinic acid.


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


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Coronary Disease, Coronary Arteriosclerosis, HyperlipidemiaA Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease
NCT00134173
  1. Birmingham, Alabama
  2. Mobile, Alabama
  3. Little Rock, Arkansas
  4. Fresno, California
  5. Los Altos, California
  6. Los Angeles, California
  7. Mountain View, California
  8. Sacramento, California
  9. San Diego, California
  10. San Francisco, California
  11. Santa Rosa, California
  12. Stockton, California
  13. Boulder, Colorado
  14. Denver, Colorado
  15. Brandford, Connecticut
  16. Farmington, Connecticut
  17. Guilford, Connecticut
  18. New Haven, Connecticut
  19. Atlantis, Florida
  20. Clearwater, Florida
  21. Dunedin, Florida
  22. Fort Lauderdale, Florida
  23. Jacksonville, Florida
  24. Largo, Florida
  25. Melbourne, Florida
  26. Miami, Florida
  27. Orlando, Florida
  28. Pensacola, Florida
  29. Safety Harbor, Florida
  30. Sarasota, Florida
  31. Tampa, Florida
  32. Blue Island, Illinois
  33. Merrionette Park, Illinois
  34. Rockford, Illinois
  35. Elkhart, Indiana
  36. Goshen, Indiana
  37. Hobart, Indiana
  38. Merrillville, Indiana
  39. Davenport, Iowa
  40. Des Moines, Iowa
  41. West Des Moines, Iowa
  42. Shawnee Mission, Kansas
  43. Louisville, Kentucky
  44. Bogalusa, Louisiana
  45. Covington, Louisiana
  46. New Orleans, Louisiana
  47. Auburn, Maine
  48. Lewiston, Maine
  49. Portland, Maine
  50. Scarborough, Maine
  51. Baltimore, Maryland
  52. Columbia, Maryland
  53. Salisbury, Maryland
  54. Takoma Park, Maryland
  55. Ann Arbor, Michigan
  56. Flint, Michigan
  57. Kalamazoo, Michigan
  58. Lapeer, Michigan
  59. Petoskey, Michigan
  60. Royal Oak, Michigan
  61. Saginaw, Michigan
  62. Ypsilanti, Michigan
  63. Duluth, Minnesota
  64. Maplewood, Minnesota
  65. Minneapolis, Minnesota
  66. St. Cloud, Minnesota
  67. St. Paul, Minnesota
  68. Southaven, Mississippi
  69. Kansas City, Missouri
  70. Omaha, Nebraska
  71. Ridgewood, New Jersey
  72. Albuquerque, New Mexico
  73. Carlsbad, New Mexico
  74. Albany, New York
  75. Bay Shore, New York
  76. Buffalo, New York
  77. Flushing, New York
  78. Johnson City, New York
  79. New York, New York
  80. Oneonta, New York
  81. Poughkeepsie, New York
  82. Rochester, New York
  83. Troy, New York
  84. Williamsville, New York
  85. Eden, North Carolina
  86. Greensboro, North Carolina
  87. Greenville, North Carolina
  88. Raleigh, North Carolina
  89. Reidsville, North Carolina
  90. Winston-Salem, North Carolina
  91. Bellevue, Ohio
  92. Cleveland, Ohio
  93. Clyde, Ohio
  94. Defiance, Ohio
  95. Fostoria, Ohio
  96. Middleburg Heights, Ohio
  97. Orange Village, Ohio
  98. Toledo, Ohio
  99. Wauseon, Ohio
  100. Westlake, Ohio
  101. Oklahoma City, Oklahoma
  102. Tulsa, Oklahoma
  103. Eugene, Oregon
  104. Florence, Oregon
  105. Hillsboro, Oregon
  106. Doylestown, Pennsylvania
  107. Harrisburg, Pennsylvania
  108. Hershey, Pennsylvania
  109. Lancaster, Pennsylvania
  110. Philadelphia, Pennsylvania
  111. Pittsburgh, Pennsylvania
  112. Wormleysburg, Pennsylvania
  113. Greenville, South Carolina
  114. Chattanooga, Tennessee
  115. Knoxville, Tennessee
  116. Memphis, Tennessee
  117. Oak Ridge, Tennessee
  118. San Antonio, Texas
  119. Annandale, Virginia
  120. Charlottesville, Virginia
  121. Falls Church, Virginia
  122. Norfolk, Virginia
  123. Richmond, Virginia
  124. Bellevue, Washington
  125. Seattle, Washington
  126. Huntington, West Virginia
  127. Milwaukee, Wisconsin
  128. Aalst,
  129. Bruxelles,
  130. Genk,
  131. Calgary, Alberta
  132. Victoria, British Columbia
  133. Halifax, Nova Scotia
  134. Ottawa, Ontario
  135. Torono, Ontario
  136. Montreal, Quebec
  137. Montréal, Quebec
  138. Nijmegen,
  139. Rotterdam,
  140. Katowice,
  141. Krakow,
  142. Warszawa,
  143. Oviedo, Asturias
  144. L´Hospitalet del Llobregat, Barcelona
  145. Vigo, Pontevedra
  146. Barcelona,
  147. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease
Official Title  ICMJE Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Angiographically Documented Coronary Heart Disease.
Brief Summary

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

To look at ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease

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
  • Coronary Disease
  • Coronary Arteriosclerosis
  • Hyperlipidemia
Intervention  ICMJE
  • Drug: torcetrapib/atorvastatin
  • Drug: atorvastatin
Study Arms  ICMJE Not Provided
Publications *

*   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: August 22, 2005)
1100
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • angiographic evidence of coronary atherosclerosis

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid.
  • Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
  • 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 to 75 Years   (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 Belgium,   Canada,   Netherlands,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00134173
Other Study ID Numbers  ICMJE A5091005
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 April 2007

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