A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease

NCT00134264

Last updated date
Study Location
Pfizer Investigational Site
Alabaster, 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]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Coronary Disease, Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events

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 evaluationof 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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Coronary Disease, Diabetes MellitusA Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease
NCT00134264
  1. Alabaster, Alabama
  2. Birmingham, Alabama
  3. Gilbert, Arizona
  4. Phoenix, Arizona
  5. Tucson, Arizona
  6. Fresno, California
  7. Los Angeles, California
  8. Modesto, California
  9. San Diego, California
  10. Santa Rosa, California
  11. Tustin, California
  12. Walnut Creek, California
  13. Denver, Colorado
  14. Longmont, Colorado
  15. Guilford, Connecticut
  16. Hartford, Connecticut
  17. Washington, District of Columbia
  18. Clearwater, Florida
  19. Coral Gables, Florida
  20. Fort Meyers, Florida
  21. Jacksonville Beach, Florida
  22. Jacksonville, Florida
  23. Lakeland, Florida
  24. Orlando, Florida
  25. Pensacola, Florida
  26. Port Charlotte, Florida
  27. Sarasota, Florida
  28. West Palm Beach, Florida
  29. Atlanta, Georgia
  30. Aurora, Illinois
  31. Blue Island, Illinois
  32. Chicago, Illinois
  33. Evansville, Indiana
  34. Fort Wayne, Indiana
  35. Davenport, Iowa
  36. des Moines, Iowa
  37. Iowa City, Iowa
  38. Wichita, Kansas
  39. Witchita, Kansas
  40. Louisville, Kentucky
  41. Baton Rouge, Louisiana
  42. Covington, Louisiana
  43. Marrero, Louisiana
  44. Scarborough, Maine
  45. Baltimore, Maryland
  46. Bel Air, Maryland
  47. Columbia, Maryland
  48. Towson, Maryland
  49. Westminster, Maryland
  50. Abington, Massachusetts
  51. Haverhill, Massachusetts
  52. Natick, Massachusetts
  53. Grand Rapids, Michigan
  54. Minneapolis, Minnesota
  55. St. Paul, Minnesota
  56. St. Louis, Missouri
  57. Billings, Montana
  58. Butte, Montana
  59. Omaha, Nebraska
  60. Papillon, Nebraska
  61. Las Vegas, Nevada
  62. Concord, New Hampshire
  63. Lebanon, New Hampshire
  64. Manchester, New Hampshire
  65. Elmer, New Jersey
  66. Haddon Heights, New Jersey
  67. New Brunswick, New Jersey
  68. Garden City, New York
  69. New Hyde Park, New York
  70. Rochester, New York
  71. Durham, North Carolina
  72. Winston-salem, North Carolina
  73. Cincinnati, Ohio
  74. Cleveland, Ohio
  75. Columbus, Ohio
  76. Mansfield, Ohio
  77. Sandusky, Ohio
  78. Toledo, Ohio
  79. Oklahoma City, Oklahoma
  80. Portland, Oregon
  81. Beaver, Pennsylvania
  82. Philadelphia, Pennsylvania
  83. Kingsport, Tennessee
  84. Nashville, Tennessee
  85. Beaumont, Texas
  86. Dallas, Texas
  87. Houston, Texas
  88. Plano, Texas
  89. San Antonio, Texas
  90. Salt Lake City, Utah
  91. Burlington, Vermont
  92. Norfolk, Virginia
  93. Richmond, Virginia
  94. Burien, Washington
  95. Tacoma, Washington
  96. Concord, New South Wales
  97. East Gosford, New South Wales
  98. St. Leonards, New South Wales
  99. Wollongong, New South Wales
  100. Chermside, Queensland
  101. Herston, Queensland
  102. Woolloongabba, Queensland
  103. Adelaide, South Australia
  104. Bedford Park, South Australia
  105. Woodville, South Australia
  106. Clayton, Victoria
  107. Fitzroy, Victoria
  108. Footscray, Victoria
  109. Heidelberg, Victoria
  110. Prahran, Victoria
  111. Fremantle, Western Australia
  112. Joondalup, Western Australia
  113. Camperdown,
  114. Darlinghurst,
  115. Geelong,
  116. Launceston, Tas,
  117. Melbourne,
  118. Nedlands,
  119. Perth,
  120. Southport,
  121. Calgary, Alberta
  122. Vancouver, British Columbia
  123. Winnipeg, Manitoba
  124. Halifax, Nova Scotia
  125. Cornwall, Ontario
  126. Newmarket, Ontario
  127. Oshawa, Ontario
  128. Sarnia, Ontario
  129. Scarborough, Ontario
  130. Toronto, Ontario
  131. Laval, Quebec
  132. Montreal, Quebec
  133. Sainte-foy, Quebec
  134. Sherbrooke, Quebec
  135. Ste-foy, Quebec
  136. Saint John's,
  137. Amsterdam,
  138. AN Rotterdam,
  139. Apeldoorn,
  140. Arnhem,
  141. Breda,
  142. Cappelle aan den IJssel,
  143. Delft,
  144. Eindhoven,
  145. Goes,
  146. Gouda,
  147. Groningen,
  148. Heerlen,
  149. Hertogenbosch,
  150. Hoorn,
  151. Leiden,
  152. Maastricht,
  153. Nijmegen,
  154. Rotterdam,
  155. Sittard,
  156. Utrecht,
  157. Velp,
  158. Venlo,
  159. Zoetermeer,
  160. Sant Coloma de Gramenet, Barcelona
  161. Terrasa, Barcelona
  162. Jerez de La Frontera, Cadiz
  163. Santander, Cantabria
  164. San Sebastian, Guipuzcoa
  165. Ferrol, La Coruna
  166. Santiago De Compostela, La Coruña
  167. Almeria,
  168. Barcelona,
  169. Ciudad Real,
  170. Granada,
  171. Madrid,
  172. Malaga,
  173. Salamanca,
  174. Sevilla,
  175. Valencia,
  176. Zaragoza,
  177. Borås,
  178. Eskilstuna,
  179. Goteborg,
  180. Göteborg,
  181. Helsingborg,
  182. Hässleholm,
  183. Karlshamn,
  184. Koping,
  185. Linköping,
  186. Lulea,
  187. Lund,
  188. Malmo,
  189. Molndal,
  190. Norrkoping,
  191. Ostersund,
  192. Skelleftea,
  193. Stockholm,
  194. Uddevalla,
  195. Uppsala,
  196. Vaxjo,
  197. Västervik,
  198. Wrexham, Clwyd
  199. Woolwich, London
  200. Glasgow, Scotland
  201. Aberdeen,
  202. Bath,
  203. Birmingham,
  204. Bournemouth,
  205. Brighton, East Sussex,
  206. Bristol,
  207. Cardiff,
  208. Chichester,
  209. Coventry,
  210. Dundee,
  211. Edinburgh,
  212. Exeter,
  213. Glasgow,
  214. Harrow,
  215. Leicester,
  216. Liverpool,
  217. London,
  218. Newcastle-upon-Tyne,
  219. Romford,
  220. Shrewsbury,
  221. Warwick,
ALL GENDERS
45 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease
Official Title  ICMJE Phase 3 Multi Center, Double Blind, Randomized, Parallel Group Evaluation Of The Fixed Combination Torcetrapib/Atorvastatin, Administered Orally, Once Daily (Qd), Compared With Atorvastatin Alone, On The Occurrence Of Major Cardiovascular Events In Subjects With Coronary Heart Disease Or Risk Equivalents
Brief Summary

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

To demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular disease events, when compared to atorvastatin alone, in patients with coronary heart disease or risk equivalents

Detailed Description Not Provided
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
  • Diabetes Mellitus
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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 30, 2012)
15067
Original Enrollment  ICMJE
 (submitted: August 22, 2005)
13000
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events

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 evaluationof response, or render unlikely that the subject would complete the study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 45 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 Australia,   Canada,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00134264
Other Study ID Numbers  ICMJE A5091043
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2012

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