- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00327691
En undersøgelse for at bestemme graden af yderligere reduktion i CV-risiko ved at sænke LDL under minimumsmålniveauer (TNT)
1. maj 2007 opdateret af: Pfizer
Effekten af LDL-kolesterol, der sænker ud over de aktuelt anbefalede minimumsmål på tilbagefald af koronar hjertesygdom (CHD) hos patienter med allerede eksisterende CHD
Det primære formål med denne undersøgelse er at bestemme graden af yderligere reduktion i kardiovaskulær risiko, som patienterne fik ved at sænke deres LDL-C ud over det aktuelt accepterede minimumsmålniveau for patienter med allerede eksisterende CHD.
Sekundære mål inkluderer sikkerhedsprofilen for denne behandlingsstrategi, dens omkostningseffektivitet, effekt på andre aterosklerotiske relaterede hændelser og procedurer og total dødelighed.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding
8600
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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- Pfizer Investigational Site
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New South Wales
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St. Leonards, New South Wales, Australien, 2065
- Pfizer Investigational Site
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Queensland
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Auchenflower, Queensland, Australien, 4066
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Brisbane, Queensland, Australien, 4029
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Chermside, Queensland, Australien, 4032
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Greenslopes, Queensland, Australien, 4130
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Herston, Queensland, Australien, 4029
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Milton, Queensland, Australien, 4064
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South Australia
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Adelaide, South Australia, Australien, 5000
- Pfizer Investigational Site
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Bedford Park, South Australia, Australien, 5042
- Pfizer Investigational Site
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Tasmania
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Hobart, Tasmania, Australien, 7000
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Victoria
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Clayton, Victoria, Australien, 3168
- Pfizer Investigational Site
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Parkville, Victoria, Australien, 3050
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Prahran, Victoria, Australien, 3181
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Western Australia
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Nedlands, Western Australia, Australien, 6009
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Aalst, Belgien, 9300
- Pfizer Investigational Site
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Antwerpen, Belgien, B-2020
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Genk, Belgien, 3600
- Pfizer Investigational Site
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Genk, Belgien, B-3600
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Godinne, Belgien, 5530
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Leuven, Belgien, 3000
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Lommel, Belgien, 3920
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Neerpelt, Belgien, 3910
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Quebec, Canada, G1R 2J6
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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, T5R 4H5
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Edmonton, Alberta, Canada, T6G 2B7
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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
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Pfizer Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
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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
- Pfizer Investigational Site
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Toronto, Ontario, Canada, M5C 2T2
- Pfizer Investigational Site
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
- Pfizer Investigational Site
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Montreal, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H1T 1C8
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Montreal, Quebec, Canada, H2W 1R7
- Pfizer Investigational Site
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Sherbrooke, Quebec, Canada, J1H 5N4
- Pfizer Investigational Site
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St-foy, Quebec, Canada, G1V 4G2
- Pfizer Investigational Site
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Barnet, Det Forenede Kongerige, EN5 3DJ
- Pfizer Investigational Site
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Glasgow, Det Forenede Kongerige, G11 6NT
- Pfizer Investigational Site
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London, Det Forenede Kongerige, E1 1BB
- Pfizer Investigational Site
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London, Det Forenede Kongerige, NW3 2PF
- Pfizer Investigational Site
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Paisley, Det Forenede Kongerige, P1 1HR
- Pfizer Investigational Site
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Essex
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Romford, Essex, Det Forenede Kongerige, RM7 OBE
- Pfizer Investigational Site
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Greater London
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London, Greater London, Det Forenede Kongerige, E2 9JX
- Pfizer Investigational Site
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London, Greater London, Det Forenede Kongerige, NW10 7NS
- Pfizer Investigational Site
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London, Greater London, Det Forenede Kongerige, SW17 0RE
- Pfizer Investigational Site
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Hampshire
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Aldershot, Hampshire, Det Forenede Kongerige, GU11 3RB
- Pfizer Investigational Site
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Kent
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Farnborough, Kent, Det Forenede Kongerige, BR6 7AR
- Pfizer Investigational Site
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Lancashire
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Blackpool, Lancashire, Det Forenede Kongerige, FY3 8NR
- Pfizer Investigational Site
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Leicestershire
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Leicester, Leicestershire, Det Forenede Kongerige, LE3 9QP
- Pfizer Investigational Site
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Middlesex
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London, Middlesex, Det Forenede Kongerige, HA8 0AD
- Pfizer Investigational Site
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West Midlands
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Coventry, West Midlands, Det Forenede Kongerige, CV1 4FH
- Pfizer Investigational Site
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Coventry, West Midlands, Det Forenede Kongerige, CV2 2DX
- Pfizer Investigational Site
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Wiltshire
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Swindon, Wiltshire, Det Forenede Kongerige, SN3 6BB
- Pfizer Investigational Site
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Alabama
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Alabaster, Alabama, Forenede Stater, 35007
- Pfizer Investigational Site
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Birmingham, Alabama, Forenede Stater, 35205-4785
- Pfizer Investigational Site
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Birmingham, Alabama, Forenede Stater, 35213
- Pfizer Investigational Site
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Birmingham, Alabama, Forenede Stater, 35294-2041
- Pfizer Investigational Site
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Hoover, Alabama, Forenede Stater, 35216
- Pfizer Investigational Site
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Montgomery, Alabama, Forenede Stater, 36117
- Pfizer Investigational Site
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Arizona
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Mesa, Arizona, Forenede Stater, 85202
- Pfizer Investigational Site
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Mesa, Arizona, Forenede Stater, 85206
- Pfizer Investigational Site
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California
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Burbank, California, Forenede Stater, 91505
- Pfizer Investigational Site
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Camp Pendleton, California, Forenede Stater, 92055
- Pfizer Investigational Site
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Fresno, California, Forenede Stater, 93703
- Pfizer Investigational Site
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La Jolla, California, Forenede Stater, 92037
- Pfizer Investigational Site
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Loma Linda, California, Forenede Stater, 92354
- Pfizer Investigational Site
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Los Angeles, California, Forenede Stater, 90048
- Pfizer Investigational Site
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Los Angeles, California, Forenede Stater, 90017-2395
- Pfizer Investigational Site
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Modesto, California, Forenede Stater, 95350
- Pfizer Investigational Site
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Pasadena, California, Forenede Stater, 91105
- Pfizer Investigational Site
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Rancho Mirage, California, Forenede Stater, 92270
- Pfizer Investigational Site
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San Diego, California, Forenede Stater, 92134-3303
- Pfizer Investigational Site
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San Francisco, California, Forenede Stater, 94143-0130
- Pfizer Investigational Site
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San Francisco, California, Forenede Stater, 94143-0326
- Pfizer Investigational Site
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Santa Rosa, California, Forenede Stater, 95403
- Pfizer Investigational Site
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Stanford, California, Forenede Stater
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Pfizer Investigational Site
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Denver, Colorado, Forenede Stater, 80220
- Pfizer Investigational Site
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Denver, Colorado, Forenede Stater, 80218
- Pfizer Investigational Site
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Denver, Colorado, Forenede Stater, 80203
- Pfizer Investigational Site
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Connecticut
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Bridgeport, Connecticut, Forenede Stater, 06610
- Pfizer Investigational Site
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Hartford, Connecticut, Forenede Stater, 06102
- Pfizer Investigational Site
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New Britain, Connecticut, Forenede Stater, 06053
- Pfizer Investigational Site
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Delaware
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Newark, Delaware, Forenede Stater, 19718
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20037
- Pfizer Investigational Site
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Florida
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Clearwater, Florida, Forenede Stater, 33756
- Pfizer Investigational Site
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Gainsville, Florida, Forenede Stater, 32608
- Pfizer Investigational Site
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Gainsville, Florida, Forenede Stater, 32610
- Pfizer Investigational Site
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Hollywood, Florida, Forenede Stater, 33021
- Pfizer Investigational Site
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Inverness, Florida, Forenede Stater, 34452
- Pfizer Investigational Site
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Lakeland, Florida, Forenede Stater, 33805
- Pfizer Investigational Site
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Miami, Florida, Forenede Stater, 33173
- Pfizer Investigational Site
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Miami, Florida, Forenede Stater, 33176
- Pfizer Investigational Site
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Ocala, Florida, Forenede Stater, 34474
- Pfizer Investigational Site
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Orlando, Florida, Forenede Stater, 32803
- Pfizer Investigational Site
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Port Charlotte, Florida, Forenede Stater, 33952
- Pfizer Investigational Site
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Sarasota, Florida, Forenede Stater, 34239
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Stuart, Florida, Forenede Stater, 34996
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Tamarac, Florida, Forenede Stater, 33321
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The Villages, Florida, Forenede Stater, 32159
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
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Canton, Georgia, Forenede Stater, 30114
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Illinois
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Berwyn, Illinois, Forenede Stater, 60402
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Blue Island, Illinois, Forenede Stater, 60406
- Pfizer Investigational Site
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Chicago, Illinois, Forenede Stater, 60611
- Pfizer Investigational Site
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Chicago, Illinois, Forenede Stater, 60610
- Pfizer Investigational Site
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DuQuoin, Illinois, Forenede Stater, 62832
- Pfizer Investigational Site
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Evanston, Illinois, Forenede Stater, 60201
- Pfizer Investigational Site
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Lake Forest, Illinois, Forenede Stater, 60045
- Pfizer Investigational Site
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Marion, Illinois, Forenede Stater, 62959
- Pfizer Investigational Site
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Pekin, Illinois, Forenede Stater, 61554
- Pfizer Investigational Site
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Peoria, Illinois, Forenede Stater, 61603
- Pfizer Investigational Site
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Peoria, Illinois, Forenede Stater, 61614
- Pfizer Investigational Site
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Indiana
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Beech Grove, Indiana, Forenede Stater, 46107
- Pfizer Investigational Site
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Evansville, Indiana, Forenede Stater, 47710
- Pfizer Investigational Site
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Fort Wayne, Indiana, Forenede Stater, 46805
- Pfizer Investigational Site
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Fort Wayne, Indiana, Forenede Stater, 46825
- Pfizer Investigational Site
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Jeffersonville, Indiana, Forenede Stater, 47130
- Pfizer Investigational Site
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Scottsburg, Indiana, Forenede Stater, 47170
- Pfizer Investigational Site
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Iowa
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Des Moines, Iowa, Forenede Stater, 50314
- Pfizer Investigational Site
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Iowa City, Iowa, Forenede Stater, 52242
- Pfizer Investigational Site
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160-7200
- Pfizer Investigational Site
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Lathe, Kansas, Forenede Stater, 66061
- Pfizer Investigational Site
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Overland Park, Kansas, Forenede Stater, 66213
- Pfizer Investigational Site
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Wichita, Kansas, Forenede Stater, 67220
- Pfizer Investigational Site
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Kentucky
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Edgewood, Kentucky, Forenede Stater, 41017
- Pfizer Investigational Site
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Erlanger, Kentucky, Forenede Stater, 41018
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Louisville, Kentucky, Forenede Stater, 40202
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Louisiana
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Marrero, Louisiana, Forenede Stater, 70072
- Pfizer Investigational Site
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New Orleans, Louisiana, Forenede Stater, 70112
- Pfizer Investigational Site
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New Orleans, Louisiana, Forenede Stater, 70121
- Pfizer Investigational Site
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Maine
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Portland, Maine, Forenede Stater, 04102
- Pfizer Investigational Site
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Maryland
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Baltimore, Maryland, Forenede Stater, 21218
- Pfizer Investigational Site
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Baltimore, Maryland, Forenede Stater, 21205
- Pfizer Investigational Site
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Baltimore, Maryland, Forenede Stater, 21287
- Pfizer Investigational Site
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Baltimore, Maryland, Forenede Stater, 21201
- Pfizer Investigational Site
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Baltimore, Maryland, Forenede Stater, 21204
- Pfizer Investigational Site
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Baltimore, Maryland, Forenede Stater, 21208
- Pfizer Investigational Site
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Baltimore, Maryland, Forenede Stater, 21224
- Pfizer Investigational Site
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Baltimore, Maryland, Forenede Stater, 21228
- Pfizer Investigational Site
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Baltimore, Maryland, Forenede Stater, 21229
- Pfizer Investigational Site
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Baltimore, Maryland, Forenede Stater, 21237
- Pfizer Investigational Site
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Bel Air, Maryland, Forenede Stater, 21014
- Pfizer Investigational Site
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Westminster, Maryland, Forenede Stater, 21157
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Pfizer Investigational Site
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Boston, Massachusetts, Forenede Stater, 02215
- Pfizer Investigational Site
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Burlington, Massachusetts, Forenede Stater, 1805
- Pfizer Investigational Site
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Michigan
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Dearborn, Michigan, Forenede Stater, 48126
- Pfizer Investigational Site
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Detroit, Michigan, Forenede Stater, 48202
- Pfizer Investigational Site
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Farmington Hill, Michigan, Forenede Stater, 48336
- Pfizer Investigational Site
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Sterling Heights, Michigan, Forenede Stater, 48310
- Pfizer Investigational Site
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West Bloomfield, Michigan, Forenede Stater, 48322
- Pfizer Investigational Site
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- Pfizer Investigational Site
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Edina, Minnesota, Forenede Stater, 55435
- Pfizer Investigational Site
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Maplewood, Minnesota, Forenede Stater, 55109
- Pfizer Investigational Site
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Minneapolis, Minnesota, Forenede Stater, 55455
- Pfizer Investigational Site
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St. Paul, Minnesota, Forenede Stater, 55102
- Pfizer Investigational Site
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Missouri
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Kansas City, Missouri, Forenede Stater, 64111
- Pfizer Investigational Site
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St. Louis, Missouri, Forenede Stater, 63110
- Pfizer Investigational Site
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St. Louis, Missouri, Forenede Stater, 63141
- Pfizer Investigational Site
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St. Louis, Missouri, Forenede Stater, 63104
- Pfizer Investigational Site
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St. Louis, Missouri, Forenede Stater, 63110-0205
- Pfizer Investigational Site
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St. Louis, Missouri, Forenede Stater, 63117
- Pfizer Investigational Site
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Nebraska
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Papillion, Nebraska, Forenede Stater, 68046
- Pfizer Investigational Site
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New Hampshire
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Manchester, New Hampshire, Forenede Stater, 03102
- Pfizer Investigational Site
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New Jersey
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New Brunswick, New Jersey, Forenede Stater, 08901
- Pfizer Investigational Site
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New York
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Albany, New York, Forenede Stater, 12208
- Pfizer Investigational Site
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Brooklyn, New York, Forenede Stater, 11203
- Pfizer Investigational Site
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Hawthorne, New York, Forenede Stater, 10535
- Pfizer Investigational Site
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Manlius, New York, Forenede Stater, 13104
- Pfizer Investigational Site
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New York, New York, Forenede Stater, 10021
- Pfizer Investigational Site
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New York, New York, Forenede Stater, 10029
- Pfizer Investigational Site
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New York, New York, Forenede Stater, 10032
- Pfizer Investigational Site
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Rochester, New York, Forenede Stater, 14618
- Pfizer Investigational Site
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Rochester, New York, Forenede Stater, 14607
- Pfizer Investigational Site
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Rochester, New York, Forenede Stater, 14621
- Pfizer Investigational Site
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Syracuse, New York, Forenede Stater, 13202
- Pfizer Investigational Site
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Syracuse, New York, Forenede Stater, 13210
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Valhalla, New York, Forenede Stater, 10595
- Pfizer Investigational Site
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28803
- Pfizer Investigational Site
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Durham, North Carolina, Forenede Stater, 27710
- Pfizer Investigational Site
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Eden, North Carolina, Forenede Stater, 27288
- Pfizer Investigational Site
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Winston-Salem, North Carolina, Forenede Stater, 27157
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Ohio
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Beachwood, Ohio, Forenede Stater, 44122
- Pfizer Investigational Site
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Cincinnati, Ohio, Forenede Stater, 45219
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Cincinnati, Ohio, Forenede Stater, 45229
- Pfizer Investigational Site
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Cincinnati, Ohio, Forenede Stater, 45246
- Pfizer Investigational Site
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Cleveland, Ohio, Forenede Stater, 44106-5038
- Pfizer Investigational Site
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Cleveland, Ohio, Forenede Stater, 44195
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Columbus, Ohio, Forenede Stater, 43210
- Pfizer Investigational Site
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Columbus, Ohio, Forenede Stater, 43221
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Kettering, Ohio, Forenede Stater, 45429-1221
- Pfizer Investigational Site
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Lorain, Ohio, Forenede Stater, 44053
- Pfizer Investigational Site
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Sandusky, Ohio, Forenede Stater, 44870
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Pfizer Investigational Site
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Tulsa, Oklahoma, Forenede Stater, 74133
- Pfizer Investigational Site
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Tulsa, Oklahoma, Forenede Stater, 74136-1920
- Pfizer Investigational Site
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Tulsa, Oklahoma, Forenede Stater, 74136
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Pfizer Investigational Site
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Portland, Oregon, Forenede Stater, 97210
- Pfizer Investigational Site
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Portland, Oregon, Forenede Stater, 97216
- Pfizer Investigational Site
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18102
- Pfizer Investigational Site
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Allentown, Pennsylvania, Forenede Stater, 18106-0880
- Pfizer Investigational Site
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Lansdale, Pennsylvania, Forenede Stater, 19446
- Pfizer Investigational Site
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Lehighton, Pennsylvania, Forenede Stater, 18235
- Pfizer Investigational Site
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Pfizer Investigational Site
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Pfizer Investigational Site
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Pfizer Investigational Site
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Sellersville, Pennsylvania, Forenede Stater, 18960
- Pfizer Investigational Site
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Rhode Island
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Pawtucket, Rhode Island, Forenede Stater, 02860
- Pfizer Investigational Site
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Providence, Rhode Island, Forenede Stater, 02906
- Pfizer Investigational Site
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29403
- Pfizer Investigational Site
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Pfizer Investigational Site
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Sioux Falls, South Dakota, Forenede Stater, 57108
- Pfizer Investigational Site
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38104
- Pfizer Investigational Site
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Memphis, Tennessee, Forenede Stater, 38105
- Pfizer Investigational Site
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Memphis, Tennessee, Forenede Stater, 38119-5209
- Pfizer Investigational Site
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Memphis, Tennessee, Forenede Stater, 38128
- Pfizer Investigational Site
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Nashville, Tennessee, Forenede Stater, 37205
- Pfizer Investigational Site
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Nashville, Tennessee, Forenede Stater, 37232-6300
- Pfizer Investigational Site
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Texas
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Austin, Texas, Forenede Stater, 78756
- Pfizer Investigational Site
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Dallas, Texas, Forenede Stater, 75246
- Pfizer Investigational Site
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Dallas, Texas, Forenede Stater, 75235
- Pfizer Investigational Site
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Dallas, Texas, Forenede Stater, 75390-9047
- Pfizer Investigational Site
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Denton, Texas, Forenede Stater, 76204
- Pfizer Investigational Site
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Houston, Texas, Forenede Stater, 77030
- Pfizer Investigational Site
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Lackland AFB, Texas, Forenede Stater, 78236-5300
- Pfizer Investigational Site
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San Antonio, Texas, Forenede Stater, 78229
- Pfizer Investigational Site
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Utah
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Salt Lake City, Utah, Forenede Stater, 84124
- Pfizer Investigational Site
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Vermont
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Burlington, Vermont, Forenede Stater, 05401
- Pfizer Investigational Site
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Virginia
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Richmond, Virginia, Forenede Stater, 23249
- Pfizer Investigational Site
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Richmond, Virginia, Forenede Stater, 23298
- Pfizer Investigational Site
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Pfizer Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53295
- Pfizer Investigational Site
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Agen, Frankrig, 47000
- Pfizer Investigational Site
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Bordeaux, Frankrig, 33000
- Pfizer Investigational Site
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Brest, Frankrig, 29200
- Pfizer Investigational Site
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Clermont-ferrand, Frankrig, 63003
- Pfizer Investigational Site
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Lyon, Frankrig, 69003
- Pfizer Investigational Site
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Marseille, Frankrig, 13915 Cedex 20
- Pfizer Investigational Site
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Paris CEDEX 05, Frankrig, 75230
- Pfizer Investigational Site
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Rennes, Frankrig, 35033
- Pfizer Investigational Site
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Roubaix Cdx, Frankrig, 59056
- Pfizer Investigational Site
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Strasbourg, Frankrig, 67091
- Pfizer Investigational Site
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Toulouse, Frankrig, 31059
- Pfizer Investigational Site
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Toulouse, Frankrig, 31400
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Cedex
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Pessac, Cedex, Frankrig, 33604
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's-Hertogenbosch, Holland, 5211 NL
- Pfizer Investigational Site
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Alkmaar, Holland, 1815 JD
- Pfizer Investigational Site
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Amersfoort, Holland, 3818 ES
- Pfizer Investigational Site
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Amsterdam, Holland, 1105 AZ
- Pfizer Investigational Site
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Breda, Holland, 4818 CK
- Pfizer Investigational Site
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Eindhoven, Holland, 5623 EJ
- Pfizer Investigational Site
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Enschede, Holland, 7513 ER
- Pfizer Investigational Site
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Groningen, Holland, 9713 GZ
- Pfizer Investigational Site
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Groningen, Holland, 9728 NZ
- Pfizer Investigational Site
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Leiden, Holland, 2333 ZA
- Pfizer Investigational Site
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Nieuwegein, Holland, 3435 CM
- Pfizer Investigational Site
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Nijmegen, Holland, 6532 SZ
- Pfizer Investigational Site
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Zwolle, Holland, 8011 JW
- Pfizer Investigational Site
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Zwolle, Holland, 8025 AB
- Pfizer Investigational Site
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Cork, Irland
- Pfizer Investigational Site
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Dublin, Irland, D8
- Pfizer Investigational Site
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Bologna, Italien, 40138
- Pfizer Investigational Site
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Bologna, Italien, 40139
- Pfizer Investigational Site
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Cuneo, Italien, 12100
- Pfizer Investigational Site
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Firenze, Italien, 50134
- Pfizer Investigational Site
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Napoli, Italien, 80131
- Pfizer Investigational Site
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Rome, Italien, 00184
- Pfizer Investigational Site
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Udine, Italien, 33100
- Pfizer Investigational Site
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Bern, Schweiz, 3010
- Pfizer Investigational Site
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Geneve 14, Schweiz, CH-1211
- Pfizer Investigational Site
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Lausanne, Schweiz, CH-1011
- Pfizer Investigational Site
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Lugano, Schweiz, 6900
- Pfizer Investigational Site
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St Gallen, Schweiz, CH-9007
- Pfizer Investigational Site
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Barcelona, Spanien, 08035
- Pfizer Investigational Site
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Barcelona, Spanien, 08036
- Pfizer Investigational Site
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Cordoba, Spanien, 14004
- Pfizer Investigational Site
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Madrid, Spanien, 28007
- Pfizer Investigational Site
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Madrid, Spanien, 28041
- Pfizer Investigational Site
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Madrid, Spanien, 28029
- Pfizer Investigational Site
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Madrid, Spanien, 28040
- Pfizer Investigational Site
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San Sebastian, Spanien, 20014
- Pfizer Investigational Site
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Santiago de Compostela, Spanien, 15706
- Pfizer Investigational Site
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Sevilla, Spanien, 41013
- Pfizer Investigational Site
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Sevilla, Spanien, 41009
- Pfizer Investigational Site
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Valladolid, Spanien, 47011
- Pfizer Investigational Site
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Zaragoza, Spanien, 50009
- Pfizer Investigational Site
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Bloemfontein, Sydafrika, 9301
- Pfizer Investigational Site
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Cape Town, Sydafrika, 7500
- Pfizer Investigational Site
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Cape Town, Sydafrika, 7405
- Pfizer Investigational Site
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Parow, Sydafrika, 7505
- Pfizer Investigational Site
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Gauteng
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Johannesburg, Gauteng, Sydafrika, 2193
- Pfizer Investigational Site
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Sunninghill, Gauteng, Sydafrika, 2157
- Pfizer Investigational Site
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Berlin, Tyskland, 13353
- Pfizer Investigational Site
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Berlin, Tyskland, 13439
- Pfizer Investigational Site
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Essen, Tyskland, 45329
- Pfizer Investigational Site
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Hamburg, Tyskland, 20246
- Pfizer Investigational Site
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Schwerte, Tyskland, D-58239
- Pfizer Investigational Site
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Tostedt, Tyskland, 21255
- Pfizer Investigational Site
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Wurzburg, Tyskland, 97070
- Pfizer Investigational Site
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Feldkirch, Østrig, A-6807
- Pfizer Investigational Site
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Oberpullendorf, Østrig, A-7350
- Pfizer Investigational Site
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Wien, Østrig, A-1090
- Pfizer Investigational Site
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Wien, Østrig, 1100
- Pfizer Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
35 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
Mænd og kvinder i alderen 35-75 år, som har tydelig CHD
Ekskluderingskriterier:
Kendt overfølsomhed over for HMG CO-A reduktasebehandling, leversygdom, tegn på sekundær hyperlipidæmi
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Det primære resultat er tiden til forekomsten af en major
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kardiovaskulær hændelse, defineret som det sammensatte resultat af
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efter kliniske endepunkter
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CHD død
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Ikke-dødelig/Ikke-procedurerelateret MI
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Genoplivet hjertestop eller fatalt/ikke-dødeligt slagtilfælde
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Sekundære resultatmål
Resultatmål |
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Forekomsten af følgende kliniske hændelser
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Større koronar hændelse (CHD-død, ikke-dødelig myokardieinfarkt eller genoplivet hjertestop)
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enhver koronar hændelse (større koronar hændelse eller CABG
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PTCA, anden revaskulariseringsprocedure, procedurerelateret myokardieinfarkt eller dokumenteret angina)
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cerebrovaskulær hændelse (fatal eller ikke-dødelig slagtilfælde, TIA)
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perifer vaskulær sygdom; hospitalsindlæggelse med primær diagnose 'CHF
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enhver kardiovaskulær hændelse (enhver af ovenstående); og dødelighed af alle årsager.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Waters DD, LaRosa JC, Barter P, Fruchart JC, Gotto AM Jr, Carter R, Breazna A, Kastelein JJ, Grundy SM. Effects of high-dose atorvastatin on cerebrovascular events in patients with stable coronary disease in the TNT (treating to new targets) study. J Am Coll Cardiol. 2006 Nov 7;48(9):1793-9. doi: 10.1016/j.jacc.2006.07.041. Epub 2006 Oct 17.
- Vogt L, Bangalore S, Fayyad R, Melamed S, Hovingh GK, DeMicco DA, Waters DD. Atorvastatin Has a Dose-Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double-Blind Randomized Controlled Trials. J Am Heart Assoc. 2019 May 7;8(9):e010827. doi: 10.1161/JAHA.118.010827.
- Bangalore S, Fayyad R, DeMicco DA, Colhoun HM, Waters DD. Body Weight Variability and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004724. doi: 10.1161/CIRCOUTCOMES.118.004724.
- Kaasenbrood L, Ray KK, Boekholdt SM, Smulders YM, LaRosa JC, Kastelein JJP, van der Graaf Y, Dorresteijn JAN, Visseren FLJ. Estimated individual lifetime benefit from PCSK9 inhibition in statin-treated patients with coronary artery disease. Heart. 2018 Oct;104(20):1699-1705. doi: 10.1136/heartjnl-2017-312510. Epub 2018 Apr 5.
- Vallejo-Vaz AJ, Fayyad R, Boekholdt SM, Hovingh GK, Kastelein JJ, Melamed S, Barter P, Waters DD, Ray KK. Triglyceride-Rich Lipoprotein Cholesterol and Risk of Cardiovascular Events Among Patients Receiving Statin Therapy in the TNT Trial. Circulation. 2018 Aug 21;138(8):770-781. doi: 10.1161/CIRCULATIONAHA.117.032318.
- Ong KL, Waters DD, Fayyad R, Vogt L, Melamed S, DeMicco DA, Rye KA, Barter PJ. Relationship of High-Density Lipoprotein Cholesterol With Renal Function in Patients Treated With Atorvastatin. J Am Heart Assoc. 2018 Jan 22;7(2):e007387. doi: 10.1161/JAHA.117.007387.
- Ports WC, Fayyad R, DeMicco DA, Laskey R, Wolk R. Effectiveness of Lipid-Lowering Statin Therapy in Patients With and Without Psoriasis. Clin Drug Investig. 2017 Aug;37(8):775-785. doi: 10.1007/s40261-017-0533-0.
- Bangalore S, Fayyad R, Laskey R, DeMicco DA, Messerli FH, Waters DD. Body-Weight Fluctuations and Outcomes in Coronary Disease. N Engl J Med. 2017 Apr 6;376(14):1332-1340. doi: 10.1056/NEJMoa1606148.
- Stam-Slob MC, van der Graaf Y, Greving JP, Dorresteijn JA, Visseren FL. Cost-Effectiveness of Intensifying Lipid-Lowering Therapy With Statins Based on Individual Absolute Benefit in Coronary Artery Disease Patients. J Am Heart Assoc. 2017 Feb 18;6(2):e004648. doi: 10.1161/JAHA.116.004648.
- Deedwania PC, Pedersen TR, DeMicco DA, Breazna A, Betteridge DJ, Hitman GA, Durrington P, Neil A; TNT, CARDS and IDEAL Steering Committees and Investigators. Differing predictive relationships between baseline LDL-C, systolic blood pressure, and cardiovascular outcomes. Int J Cardiol. 2016 Nov 1;222:548-556. doi: 10.1016/j.ijcard.2016.07.201. Epub 2016 Jul 30.
- Byun YS, Lee JH, Arsenault BJ, Yang X, Bao W, DeMicco D, Laskey R, Witztum JL, Tsimikas S; TNT Trial Investigators. Relationship of oxidized phospholipids on apolipoprotein B-100 to cardiovascular outcomes in patients treated with intensive versus moderate atorvastatin therapy: the TNT trial. J Am Coll Cardiol. 2015 Apr 7;65(13):1286-1295. doi: 10.1016/j.jacc.2015.01.050.
- Arsenault BJ, Barter P, DeMicco DA, Bao W, Preston GM, LaRosa JC, Grundy SM, Deedwania P, Greten H, Wenger NK, Shepherd J, Waters DD, Kastelein JJ; Treating to New Targets (TNT) Investigators. Prediction of cardiovascular events in statin-treated stable coronary patients of the treating to new targets randomized controlled trial by lipid and non-lipid biomarkers. PLoS One. 2014 Dec 22;9(12):e114519. doi: 10.1371/journal.pone.0114519. eCollection 2014.
- Dorresteijn JA, Boekholdt SM, van der Graaf Y, Kastelein JJ, LaRosa JC, Pedersen TR, DeMicco DA, Ridker PM, Cook NR, Visseren FL. High-dose statin therapy in patients with stable coronary artery disease: treating the right patients based on individualized prediction of treatment effect. Circulation. 2013 Jun 25;127(25):2485-93. doi: 10.1161/CIRCULATIONAHA.112.000712. Epub 2013 May 14.
- Semb AG, Kvien TK, DeMicco DA, Fayyad R, Wun CC, LaRosa JC, Betteridge J, Pedersen TR, Holme I. Effect of intensive lipid-lowering therapy on cardiovascular outcome in patients with and those without inflammatory joint disease. Arthritis Rheum. 2012 Sep;64(9):2836-46. doi: 10.1002/art.34524.
- Huijgen R, Boekholdt SM, Arsenault BJ, Bao W, Davaine JM, Tabet F, Petrides F, Rye KA, DeMicco DA, Barter PJ, Kastelein JJ, Lambert G. Plasma PCSK9 levels and clinical outcomes in the TNT (Treating to New Targets) trial: a nested case-control study. J Am Coll Cardiol. 2012 May 15;59(20):1778-84. doi: 10.1016/j.jacc.2011.12.043.
- Mora S, Wenger NK, Demicco DA, Breazna A, Boekholdt SM, Arsenault BJ, Deedwania P, Kastelein JJ, Waters DD. Determinants of residual risk in secondary prevention patients treated with high- versus low-dose statin therapy: the Treating to New Targets (TNT) study. Circulation. 2012 Apr 24;125(16):1979-87. doi: 10.1161/CIRCULATIONAHA.111.088591. Epub 2012 Mar 29.
- Arsenault BJ, Boekholdt SM, Hovingh GK, Hyde CL, DeMicco DA, Chatterjee A, Barter P, Deedwania P, Waters DD, LaRosa JC, Pedersen TR, Kastelein JJ; TNT and IDEAL Investigators. The 719Arg variant of KIF6 and cardiovascular outcomes in statin-treated, stable coronary patients of the treating to new targets and incremental decrease in end points through aggressive lipid-lowering prospective studies. Circ Cardiovasc Genet. 2012 Feb 1;5(1):51-7. doi: 10.1161/CIRCGENETICS.111.960252. Epub 2011 Dec 1.
- Arsenault BJ, Barter P, DeMicco DA, Bao W, Preston GM, LaRosa JC, Grundy SM, Deedwania P, Greten H, Wenger NK, Shepherd J, Waters DD, Kastelein JJ; TNT Study Investigators. Prediction of cardiovascular events in statin-treated stable coronary patients by lipid and nonlipid biomarkers. J Am Coll Cardiol. 2011 Jan 4;57(1):63-9. doi: 10.1016/j.jacc.2010.06.052.
- Hyde CL, Macinnes A, Sanders FA, Thompson JF, Mazzarella RA, Faergeman O, van Wijk DF, Wood L, Lira M, Paciga SA. Genetic association of the CCR5 region with lipid levels in at-risk cardiovascular patients. Circ Cardiovasc Genet. 2010 Apr;3(2):162-8. doi: 10.1161/CIRCGENETICS.109.897793. Epub 2010 Feb 3.
- Waters DD. Clinical insights from the Treating to New Targets trial. Prog Cardiovasc Dis. 2009 May-Jun;51(6):487-502. doi: 10.1016/j.pcad.2009.01.001.
- Shepherd J, Kastelein JP, Bittner VA, Carmena R, Deedwania PC, Breazna A, Dobson S, Wilson DJ, Zuckerman AL, Wenger NK; Treating to New Targets Steering Committee and Investigators. Intensive lipid lowering with atorvastatin in patients with coronary artery disease, diabetes, and chronic kidney disease. Mayo Clin Proc. 2008 Aug;83(8):870-9.
- Shah SJ, Waters DD, Barter P, Kastelein JJ, Shepherd J, Wenger NK, DeMicco DA, Breazna A, LaRosa JC. Intensive lipid-lowering with atorvastatin for secondary prevention in patients after coronary artery bypass surgery. J Am Coll Cardiol. 2008 May 20;51(20):1938-43. doi: 10.1016/j.jacc.2007.12.054.
- Shepherd J, Kastelein JJ, Bittner V, Deedwania P, Breazna A, Dobson S, Wilson DJ, Zuckerman A, Wenger NK; TNT (Treating to New Targets) Investigators. Intensive lipid lowering with atorvastatin in patients with coronary heart disease and chronic kidney disease: the TNT (Treating to New Targets) study. J Am Coll Cardiol. 2008 Apr 15;51(15):1448-54. doi: 10.1016/j.jacc.2007.11.072.
- Barter P, Gotto AM, LaRosa JC, Maroni J, Szarek M, Grundy SM, Kastelein JJ, Bittner V, Fruchart JC; Treating to New Targets Investigators. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med. 2007 Sep 27;357(13):1301-10. doi: 10.1056/NEJMoa064278.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 1998
Primær færdiggørelse
7. december 2022
Studieafslutning
1. august 2004
Datoer for studieregistrering
Først indsendt
16. maj 2006
Først indsendt, der opfyldte QC-kriterier
16. maj 2006
Først opslået (Skøn)
18. maj 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. maj 2007
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. maj 2007
Sidst verificeret
1. maj 2007
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Karsygdomme
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Åreforkalkning
- Arterielle okklusive sygdomme
- Hjertesygdomme
- Slag
- Koronararteriesygdom
- Myokardieiskæmi
- Koronar sygdom
- Hjerte-kar-sygdomme
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter
- Antikolesteræmiske midler
- Hypolipidæmiske midler
- Lipidregulerende midler
- Hydroxymethylglutaryl-CoA-reduktasehæmmere
- Atorvastatin
Andre undersøgelses-id-numre
- 0981-117
- A2581136
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .