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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00327691
First received: May 16, 2006
Last updated: May 1, 2007
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Cerebrovascular Accident
Coronary Heart Disease
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary outcome is the time to occurrence of a major
  • cardiovascular event, defined as the composite outcome of the
  • following clinical endpoints
  • CHD death
  • Non-fatal/Non-procedure related MI
  • Resuscitated cardiac arrest or fatal/non-fatal stroke

Secondary Outcome Measures:
  • The occurrence of the following clinical events
  • Major coronary event (CHD death, non fatal myocardial infarction or resuscitated cardiac arrest)
  • any coronary event (major coronary event or CABG
  • PTCA, other revascularization procedure, procedure-related myocardial infarction, or documented angina)
  • cerebrovascular event (fatal or non fatal stroke, TIA)
  • peripheral vascular disease; hospitalization with primary diagnosis' of CHF
  • any cardiovascular event (any of the above); and all-cause mortality.

Estimated Enrollment: 8600
Study Start Date: April 1998
Estimated Study Completion Date: August 2004
  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327691

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Locations
United States, Alabama
Pfizer Investigational Site
Alabaster, Alabama, United States, 35007
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-2041
Pfizer Investigational Site
Birmingham, Alabama, United States, 35213
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205-4785
Pfizer Investigational Site
Hoover, Alabama, United States, 35216
Pfizer Investigational Site
Montgomery, Alabama, United States, 36117
United States, Arizona
Pfizer Investigational Site
Mesa, Arizona, United States, 85202
Pfizer Investigational Site
Mesa, Arizona, United States, 85206
United States, California
Pfizer Investigational Site
Burbank, California, United States, 91505
Pfizer Investigational Site
Camp Pendleton, California, United States, 92055
Pfizer Investigational Site
Fresno, California, United States, 93703
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
Loma Linda, California, United States, 92354
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Los Angeles, California, United States, 90048
Pfizer Investigational Site
Los Angeles, California, United States, 90017-2395
Pfizer Investigational Site
Modesto, California, United States, 95350
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Pasadena, California, United States, 91105
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Rancho Mirage, California, United States, 92270
Pfizer Investigational Site
San Diego, California, United States, 92134-3303
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San Francisco, California, United States, 94143-0326
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San Francisco, California, United States, 94143-0130
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Santa Rosa, California, United States, 95403
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Stanford, California, United States
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80012
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Denver, Colorado, United States, 80220
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Denver, Colorado, United States, 80203
Pfizer Investigational Site
Denver, Colorado, United States, 80218
United States, Connecticut
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Bridgeport, Connecticut, United States, 06610
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Hartford, Connecticut, United States, 06102
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New Britain, Connecticut, United States, 06053
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19718
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20037
United States, Florida
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Clearwater, Florida, United States, 33756
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Gainsville, Florida, United States, 32610
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Gainsville, Florida, United States, 32608
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Hollywood, Florida, United States, 33021
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Inverness, Florida, United States, 34452
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Lakeland, Florida, United States, 33805
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Miami, Florida, United States, 33176
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Miami, Florida, United States, 33173
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Ocala, Florida, United States, 34474
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Orlando, Florida, United States, 32803
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Port Charlotte, Florida, United States, 33952
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Sarasota, Florida, United States, 34239
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Stuart, Florida, United States, 34996
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Tamarac, Florida, United States, 33321
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The Villages, Florida, United States, 32159
United States, Georgia
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Atlanta, Georgia, United States, 30309
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Canton, Georgia, United States, 30114
United States, Illinois
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Berwyn, Illinois, United States, 60402
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Blue Island, Illinois, United States, 60406
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Chicago, Illinois, United States, 60610
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Chicago, Illinois, United States, 60611
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DuQuoin, Illinois, United States, 62832
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Evanston, Illinois, United States, 60201
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Lake Forest, Illinois, United States, 60045
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Marion, Illinois, United States, 62959
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Pekin, Illinois, United States, 61554
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Peoria, Illinois, United States, 61603
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Peoria, Illinois, United States, 61614
United States, Indiana
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Beech Grove, Indiana, United States, 46107
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Evansville, Indiana, United States, 47710
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Fort Wayne, Indiana, United States, 46805
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Fort Wayne, Indiana, United States, 46825
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Jeffersonville, Indiana, United States, 47130
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Scottsburg, Indiana, United States, 47170
United States, Iowa
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Des Moines, Iowa, United States, 50314
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Iowa City, Iowa, United States, 52242
United States, Kansas
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Kansas City, Kansas, United States, 66160-7200
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Lathe, Kansas, United States, 66061
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Overland Park, Kansas, United States, 66213
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Wichita, Kansas, United States, 67220
United States, Kentucky
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Edgewood, Kentucky, United States, 41017
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Erlanger, Kentucky, United States, 41018
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Louisville, Kentucky, United States, 40202
United States, Louisiana
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Marrero, Louisiana, United States, 70072
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New Orleans, Louisiana, United States, 70112
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New Orleans, Louisiana, United States, 70121
United States, Maine
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Portland, Maine, United States, 04102
United States, Maryland
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Baltimore, Maryland, United States, 21205
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Baltimore, Maryland, United States, 21287
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Baltimore, Maryland, United States, 21218
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Baltimore, Maryland, United States, 21201
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Baltimore, Maryland, United States, 21204
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Baltimore, Maryland, United States, 21208
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Baltimore, Maryland, United States, 21224
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Baltimore, Maryland, United States, 21228
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Baltimore, Maryland, United States, 21229
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Baltimore, Maryland, United States, 21237
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Bel Air, Maryland, United States, 21014
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Westminster, Maryland, United States, 21157
United States, Massachusetts
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Boston, Massachusetts, United States, 02111
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Boston, Massachusetts, United States, 02215
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Burlington, Massachusetts, United States, 1805
United States, Michigan
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Dearborn, Michigan, United States, 48126
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Detroit, Michigan, United States, 48202
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Farmington Hill, Michigan, United States, 48336
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Sterling Heights, Michigan, United States, 48310
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West Bloomfield, Michigan, United States, 48322
United States, Minnesota
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Duluth, Minnesota, United States, 55805
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Edina, Minnesota, United States, 55435
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Maplewood, Minnesota, United States, 55109
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Minneapolis, Minnesota, United States, 55455
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St. Paul, Minnesota, United States, 55102
United States, Missouri
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Kansas City, Missouri, United States, 64111
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St. Louis, Missouri, United States, 63110-0205
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St. Louis, Missouri, United States, 63117
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St. Louis, Missouri, United States, 63110
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St. Louis, Missouri, United States, 63104
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St. Louis, Missouri, United States, 63141
United States, Nebraska
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Papillion, Nebraska, United States, 68046
United States, New Hampshire
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Manchester, New Hampshire, United States, 03102
United States, New Jersey
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New Brunswick, New Jersey, United States, 08901
United States, New York
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Albany, New York, United States, 12208
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Brooklyn, New York, United States, 11203
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Hawthorne, New York, United States, 10535
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Manlius, New York, United States, 13104
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New York, New York, United States, 10021
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New York, New York, United States, 10032
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New York, New York, United States, 10029
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Rochester, New York, United States, 14607
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Rochester, New York, United States, 14618
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Rochester, New York, United States, 14621
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Syracuse, New York, United States, 13202
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Syracuse, New York, United States, 13210
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Valhalla, New York, United States, 10595
United States, North Carolina
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Asheville, North Carolina, United States, 28803
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
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Eden, North Carolina, United States, 27288
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
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Beachwood, Ohio, United States, 44122
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Cincinnati, Ohio, United States, 45246
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Cincinnati, Ohio, United States, 45219
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Cincinnati, Ohio, United States, 45229
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Cleveland, Ohio, United States, 44106-5038
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Cleveland, Ohio, United States, 44195
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Columbus, Ohio, United States, 43210
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Columbus, Ohio, United States, 43221
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Kettering, Ohio, United States, 45429-1221
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Lorain, Ohio, United States, 44053
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Sandusky, Ohio, United States, 44870
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74136
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74136-1920
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74133
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
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Portland, Oregon, United States, 97210
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Portland, Oregon, United States, 97216
United States, Pennsylvania
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Allentown, Pennsylvania, United States, 18102
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Allentown, Pennsylvania, United States, 18106-0880
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Lansdale, Pennsylvania, United States, 19446
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Lehighton, Pennsylvania, United States, 18235
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Philadelphia, Pennsylvania, United States, 19104
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Philadelphia, Pennsylvania, United States, 19107
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Pittsburgh, Pennsylvania, United States, 15213
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Sellersville, Pennsylvania, United States, 18960
United States, Rhode Island
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Pawtucket, Rhode Island, United States, 02860
Pfizer Investigational Site
Providence, Rhode Island, United States, 02906
United States, South Carolina
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Charleston, South Carolina, United States, 29403
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57105
Pfizer Investigational Site
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
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Memphis, Tennessee, United States, 38105
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119-5209
Pfizer Investigational Site
Memphis, Tennessee, United States, 38104
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Memphis, Tennessee, United States, 38128
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Nashville, Tennessee, United States, 37205
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Nashville, Tennessee, United States, 37232-6300
United States, Texas
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Austin, Texas, United States, 78756
Pfizer Investigational Site
Dallas, Texas, United States, 75390-9047
Pfizer Investigational Site
Dallas, Texas, United States, 75235
Pfizer Investigational Site
Dallas, Texas, United States, 75246
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Denton, Texas, United States, 76204
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Houston, Texas, United States, 77030
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Lackland AFB, Texas, United States, 78236-5300
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84124
United States, Vermont
Pfizer Investigational Site
Burlington, Vermont, United States, 05401
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23298
Pfizer Investigational Site
Richmond, Virginia, United States, 23249
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53295
Australia, New South Wales
Pfizer Investigational Site
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
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Auchenflower, Queensland, Australia, 4066
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Brisbane, Queensland, Australia, 4029
Pfizer Investigational Site
Chermside, Queensland, Australia, 4032
Pfizer Investigational Site
Greenslopes, Queensland, Australia, 4130
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Herston, Queensland, Australia, 4029
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Milton, Queensland, Australia, 4064
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
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Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Pfizer Investigational Site
Hobart, Tasmania, Australia, 7000
Australia, Victoria
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Clayton, Victoria, Australia, 3168
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Parkville, Victoria, Australia, 3050
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Prahran, Victoria, Australia, 3181
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Austria
Pfizer Investigational Site
Feldkirch, Austria, A-6807
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Oberpullendorf, Austria, A-7350
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Wien, Austria, A-1090
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Wien, Austria, 1100
Belgium
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Aalst, Belgium, 9300
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Antwerpen, Belgium, B-2020
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Genk, Belgium, 3600
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Genk, Belgium, B-3600
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Godinne, Belgium, 5530
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Leuven, Belgium, 3000
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Lommel, Belgium, 3920
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Neerpelt, Belgium, 3910
Canada, Alberta
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Calgary, Alberta, Canada, T2E 7C5
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Calgary, Alberta, Canada, T2N 4N1
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Edmonton, Alberta, Canada, T6G 2B7
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Edmonton, Alberta, Canada, T5R 4H5
Canada, British Columbia
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Nanaimo, British Columbia, Canada, V9S 2B8
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Vancouver, British Columbia, Canada, V6R 1Y6
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Victoria, British Columbia, Canada, V8T 5G4
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
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Hamilton, Ontario, Canada, L8L 2X2
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London, Ontario, Canada, N6A 4G5
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Ottawa, Ontario, Canada, K1Y 4W7
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Sudbury, Ontario, Canada, P3E 1B8
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Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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Montreal, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H2W 1R7
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Montreal, Quebec, Canada, H1T 1C8
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Sherbrooke, Quebec, Canada, J1H 5N4
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St-foy, Quebec, Canada, G1V 4G2
Canada
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Quebec, Canada, G1R 2J6
France
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Pessac, Cedex, France, 33604
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Agen, France, 47000
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Bordeaux, France, 33000
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Brest, France, 29200
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Clermont-ferrand, France, 63003
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Lyon, France, 69003
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Marseille, France, 13915 Cedex 20
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Paris CEDEX 05, France, 75230
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Rennes, France, 35033
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Roubaix Cdx, France, 59056
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Strasbourg, France, 67091
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Toulouse, France, 31400
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Toulouse, France, 31059
Germany
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Berlin, Germany, 13439
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Berlin, Germany, 13353
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Essen, Germany, 45329
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Hamburg, Germany, 20246
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Schwerte, Germany, D-58239
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Tostedt, Germany, 21255
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Wurzburg, Germany, 97070
Ireland
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Cork, Ireland
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Dublin, Ireland, D8
Italy
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Bologna, Italy, 40138
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Bologna, Italy, 40139
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Cuneo, Italy, 12100
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Firenze, Italy, 50134
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Napoli, Italy, 80131
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Rome, Italy, 00184
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Udine, Italy, 33100
Netherlands
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's-Hertogenbosch, Netherlands, 5211 NL
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Alkmaar, Netherlands, 1815 JD
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Amersfoort, Netherlands, 3818 ES
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Amsterdam, Netherlands, 1105 AZ
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Breda, Netherlands, 4818 CK
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Eindhoven, Netherlands, 5623 EJ
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Enschede, Netherlands, 7513 ER
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Groningen, Netherlands, 9728 NZ
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Groningen, Netherlands, 9713 GZ
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Leiden, Netherlands, 2333 ZA
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Nieuwegein, Netherlands, 3435 CM
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Nijmegen, Netherlands, 6532 SZ
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Zwolle, Netherlands, 8025 AB
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Zwolle, Netherlands, 8011 JW
South Africa
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Johannesburg, Gauteng, South Africa, 2193
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Sunninghill, Gauteng, South Africa, 2157
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Bloemfontein, South Africa, 9301
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Cape Town, South Africa, 7405
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Cape Town, South Africa, 7500
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Parow, South Africa, 7505
Spain
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Unknown, Madrid, Spain, 28040
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Barcelona, Spain, 08035
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Barcelona, Spain, 08036
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Cordoba, Spain, 14004
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Madrid, Spain, 28029
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Madrid, Spain, 28041
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Madrid, Spain, 28007
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Madrid, Spain, 28040
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San Sebastian, Spain, 20014
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Santiago de Compostela, Spain, 15706
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Sevilla, Spain, 41013
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Sevilla, Spain, 41009
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Valladolid, Spain, 47011
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Zaragoza, Spain, 50009
Switzerland
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Bern, Switzerland, 3010
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Geneve 14, Switzerland, CH-1211
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Lausanne, Switzerland, CH-1011
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Lugano, Switzerland, 6900
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St Gallen, Switzerland, CH-9007
United Kingdom
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Romford, Essex, United Kingdom, RM7 OBE
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London, Greater London, United Kingdom, NW10 7NS
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London, Greater London, United Kingdom, SW17 0RE
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London, Greater London, United Kingdom, E2 9JX
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Aldershot, Hampshire, United Kingdom, GU11 3RB
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Farnborough, Kent, United Kingdom, BR6 7AR
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Blackpool, Lancashire, United Kingdom, FY3 8NR
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Leicester, Leicestershire, United Kingdom, LE3 9QP
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London, Middlesex, United Kingdom, HA8 0AD
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Coventry, West Midlands, United Kingdom, CV1 4FH
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Coventry, West Midlands, United Kingdom, CV2 2DX
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Swindon, Wiltshire, United Kingdom, SN3 6BB
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Barnet, United Kingdom, EN5 3DJ
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Glasgow, United Kingdom, G11 6NT
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London, United Kingdom, E1 1BB
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London, United Kingdom, NW3 2PF
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Paisley, United Kingdom, P1 1HR
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00327691     History of Changes
Other Study ID Numbers: 0981-117, A2581136
Study First Received: May 16, 2006
Last Updated: May 1, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Major cardiovascular event
Major Coronary event
Revascularization

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cerebral Infarction
Stroke
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014