A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels

NCT00327691

Last updated date
Study Location
Pfizer Investigational Site
Alabaster, Alabama, 35007, 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:

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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.
Cardiovascular Disease, Cerebrovascular Accident, Coronary Heart Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Men and women age 35-75 who have evident CHD

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


Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary
hyperlipidemia

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Cardiovascular Disease, Cerebrovascular Accident, Coronary Heart DiseaseA Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels
NCT00327691
  1. Alabaster, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Birmingham, Alabama
  5. Hoover, Alabama
  6. Montgomery, Alabama
  7. Mesa, Arizona
  8. Mesa, Arizona
  9. Burbank, California
  10. Camp Pendleton, California
  11. Fresno, California
  12. La Jolla, California
  13. Loma Linda, California
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  16. Modesto, California
  17. Pasadena, California
  18. Rancho Mirage, California
  19. San Diego, California
  20. San Francisco, California
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  22. Santa Rosa, California
  23. Stanford, California
  24. Aurora, Colorado
  25. Denver, Colorado
  26. Denver, Colorado
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  29. Hartford, Connecticut
  30. New Britain, Connecticut
  31. Newark, Delaware
  32. Washington, District of Columbia
  33. Clearwater, Florida
  34. Gainsville, Florida
  35. Gainsville, Florida
  36. Hollywood, Florida
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  79. Portland, Maine
  80. Baltimore, Maryland
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  93. Boston, Massachusetts
  94. Burlington, Massachusetts
  95. Dearborn, Michigan
  96. Detroit, Michigan
  97. Farmington Hill, Michigan
  98. Sterling Heights, Michigan
  99. West Bloomfield, Michigan
  100. Duluth, Minnesota
  101. Edina, Minnesota
  102. Maplewood, Minnesota
  103. Minneapolis, Minnesota
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  111. Papillion, Nebraska
  112. Manchester, New Hampshire
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  114. Albany, New York
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  190. Bedford Park, South Australia
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  209. Calgary, Alberta
  210. Edmonton, Alberta
  211. Edmonton, Alberta
  212. Nanaimo, British Columbia
  213. Vancouver, British Columbia
  214. Victoria, British Columbia
  215. Winnipeg, Manitoba
  216. St. John's, Newfoundland and Labrador
  217. Halifax, Nova Scotia
  218. Hamilton, Ontario
  219. London, Ontario
  220. Ottawa, Ontario
  221. Sudbury, Ontario
  222. Toronto, Ontario
  223. Chicoutimi, Quebec
  224. Montreal, Quebec
  225. Montreal, Quebec
  226. Montreal, Quebec
  227. Sherbrooke, Quebec
  228. St-foy, Quebec
  229. Quebec,
  230. Pessac, Cedex
  231. Agen,
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  240. Strasbourg,
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  260. Alkmaar,
  261. Amersfoort,
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  263. Breda,
  264. Eindhoven,
  265. Enschede,
  266. Groningen,
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  270. Nijmegen,
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  274. Sunninghill, Gauteng
  275. Bloemfontein,
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  279. Barcelona,
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  290. Valladolid,
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  294. Lausanne,
  295. Lugano,
  296. St Gallen,
  297. Romford, Essex
  298. London, Greater London
  299. London, Greater London
  300. London, Greater London
  301. Aldershot, Hampshire
  302. Farnborough, Kent
  303. Blackpool, Lancashire
  304. Leicester, Leicestershire
  305. London, Middlesex
  306. Coventry, West Midlands
  307. Coventry, West Midlands
  308. Swindon, Wiltshire
  309. Barnet,
  310. Glasgow,
  311. London,
  312. London,
  313. Paisley,
ALL GENDERS
35 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels
Official Title  ICMJE The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD
Brief Summary The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Cerebrovascular Accident
  • Coronary Heart Disease
Intervention  ICMJE 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: May 16, 2006)
8600
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Men and women age 35-75 who have evident CHD

Exclusion Criteria:

Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary hyperlipidemia

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 35 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,   Austria,   Belgium,   Canada,   France,   Germany,   Ireland,   Italy,   Netherlands,   South Africa,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00327691
Other Study ID Numbers  ICMJE 0981-117
A2581136
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 May 2007

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