NCT00159835

Brief Summary

To investigate whether a long-term strategy to lower LDL cholesterol with atorvastatin as much as possible will improve prognosis in CHD patients compared with a strategy reflecting current best clinical practice with simvastatin.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,600

participants targeted

Target at P75+ for phase_4 cardiovascular-diseases

Timeline
Completed

Started Feb 1999

Longer than P75 for phase_4 cardiovascular-diseases

Geographic Reach
6 countries

193 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

First QC Date

September 8, 2005

Last Update Submit

April 21, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to of a major coronary event: 1) non-fatal acute myocardial infarction 2) coronary death 3) resuscitated cardiac arrest

Secondary Outcomes (1)

  • 1) Time to any CHD event, 2) Time to Hospitalization with primary diagnosis of CHF, 3) Time to Cerbrovascular Event, 4) Time to PAD, 5) Time to any CV event and 6) All Cause Mortality

Interventions

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Previous myocardial infarction

You may not qualify if:

  • Women who are breast feeding or are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (194)

Pfizer Investigational Site

Arhus C, DK-8000, Denmark

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Pfizer Investigational Site

Copenhagen, 2100, Denmark

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Pfizer Investigational Site

Elsinore, 3000, Denmark

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Pfizer Investigational Site

Esbjerg, 6700, Denmark

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Pfizer Investigational Site

Fredericia, 7000, Denmark

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Pfizer Investigational Site

Frederiksberg, 2000, Denmark

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Pfizer Investigational Site

Frederikssund, 3600, Denmark

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Pfizer Investigational Site

Grenå, 8500, Denmark

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Pfizer Investigational Site

Hjørring, 9800, Denmark

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Pfizer Investigational Site

Holbak, 4300, Denmark

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Pfizer Investigational Site

Holstebro, 7500, Denmark

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Pfizer Investigational Site

Hvidovre, 2650, Denmark

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Pfizer Investigational Site

Kabenhavn S, 2300, Denmark

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Pfizer Investigational Site

Kalundborg, 4400, Denmark

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Pfizer Investigational Site

København NV, 2400, Denmark

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Pfizer Investigational Site

Kobenhavn K, 1256, Denmark

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Pfizer Investigational Site

København NV, 2400, Denmark

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Pfizer Investigational Site

Køge, 4600, Denmark

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Pfizer Investigational Site

Middelfart, 5500, Denmark

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Pfizer Investigational Site

Nykøbing Falster, 4800, Denmark

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Pfizer Investigational Site

Næstved, 4700, Denmark

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Pfizer Investigational Site

Odder, 8300, Denmark

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Pfizer Investigational Site

Randers, 8900, Denmark

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Pfizer Investigational Site

Roskilde, 4000, Denmark

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Pfizer Investigational Site

Silkeborg, 8600, Denmark

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Pfizer Investigational Site

Skive, 7800, Denmark

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Pfizer Investigational Site

Slagelse, 4200, Denmark

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Pfizer Investigational Site

Svendborg, 5700, Denmark

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Pfizer Investigational Site

Ekenäs, 10600, Finland

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Pfizer Investigational Site

Heinola, 18100, Finland

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Pfizer Investigational Site

Helsinki, 00029, Finland

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Pfizer Investigational Site

Helsinki, 00100, Finland

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Pfizer Investigational Site

Joensuu, 80210, Finland

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Pfizer Investigational Site

Jyväskylä, 40100, Finland

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Pfizer Investigational Site

Kerava, 04200, Finland

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Pfizer Investigational Site

Kuopio, 70210, Finland

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Pfizer Investigational Site

Lahti, 15110, Finland

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Pfizer Investigational Site

Lappeenranta, 53130, Finland

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Pfizer Investigational Site

Lohja, 08200, Finland

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Pfizer Investigational Site

Mikkeli, 50100, Finland

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Pfizer Investigational Site

Rauma, 26100, Finland

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Pfizer Investigational Site

Salo, 24130, Finland

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Pfizer Investigational Site

Siaraalamaki, 45750, Finland

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Pfizer Investigational Site

Tampere, 33520, Finland

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Pfizer Investigational Site

Vantaa, 01400, Finland

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Pfizer Investigational Site

Reykjavik, 101, Iceland

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Pfizer Investigational Site

Reykjavik, 108, Iceland

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Pfizer Investigational Site

's-Hertogenbosch, 5211 NL, Netherlands

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Pfizer Investigational Site

Alkmaar, 1815 JD, Netherlands

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Pfizer Investigational Site

Amsterdam, 1061 AE, Netherlands

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Pfizer Investigational Site

Assen, 9401 RK, Netherlands

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Pfizer Investigational Site

Breda, 4818 CK, Netherlands

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Pfizer Investigational Site

Capelle aan den IJssel, 2906 ZC, Netherlands

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Pfizer Investigational Site

Delft, 2625 AD, Netherlands

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Pfizer Investigational Site

Deventer, 7415 CM, Netherlands

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Pfizer Investigational Site

Ede, 6716 RP, Netherlands

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Pfizer Investigational Site

Eindhoven, 5623 EJ, Netherlands

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Pfizer Investigational Site

Enschede, 7511 JX, Netherlands

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Pfizer Investigational Site

Goes, 4462 RA, Netherlands

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Pfizer Investigational Site

Groningen, 9721 SW, Netherlands

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Pfizer Investigational Site

Hoorn, 1624 GM, Netherlands

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Pfizer Investigational Site

Nijmegen, 6532 SZ, Netherlands

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Pfizer Investigational Site

Oss, NL-5342 BT, Netherlands

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Pfizer Investigational Site

Rotterdam, 3045 PM, Netherlands

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Pfizer Investigational Site

Tilburg, 5022 GC, Netherlands

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Pfizer Investigational Site

Tilurg, 5022 GC, Netherlands

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Pfizer Investigational Site

Utrecht, NL-3508-TG, Netherlands

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Pfizer Investigational Site

Weert, 6001 BE, Netherlands

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Pfizer Investigational Site

Zwijndrecht, 3331 LZ, Netherlands

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Pfizer Investigational Site

Zwolle, 8011 JW, Netherlands

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Pfizer Investigational Site

Ålesund, 6002, Norway

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Pfizer Investigational Site

Ålesund, 6026, Norway

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Pfizer Investigational Site

Bergen, 5008, Norway

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Pfizer Investigational Site

Bergen, 5009, Norway

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Pfizer Investigational Site

Bergen, 5012, Norway

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Pfizer Investigational Site

Bergen, 5015, Norway

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Pfizer Investigational Site

Bergen, 5021, Norway

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Pfizer Investigational Site

Bodø, 8092, Norway

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Pfizer Investigational Site

Flekkefjord, 4400, Norway

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Pfizer Investigational Site

Førde, 6807, Norway

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Pfizer Investigational Site

Hammerfest, 9613, Norway

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Pfizer Investigational Site

Haugesund, 5500, Norway

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Pfizer Investigational Site

Hobøl, 1827, Norway

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Pfizer Investigational Site

Jessheim, 2050, Norway

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Pfizer Investigational Site

Karasjok, 9735, Norway

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Pfizer Investigational Site

Kongsberg, 3600, Norway

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Pfizer Investigational Site

Kongsvinger, 2226, Norway

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Pfizer Investigational Site

Kragerø, 3770, Norway

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Pfizer Investigational Site

Kristiansand, 4612, Norway

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Pfizer Investigational Site

Kristiansund N, 6508, Norway

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Pfizer Investigational Site

Larvik, 3257, Norway

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Pfizer Investigational Site

Levanger, 7600, Norway

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Pfizer Investigational Site

Lillestom, 2000, Norway

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Pfizer Investigational Site

Lorenskog, 1478, Norway

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Pfizer Investigational Site

Mo i Rana, 8607, Norway

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Pfizer Investigational Site

Molde, 6407, Norway

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Pfizer Investigational Site

Molde, 6415, Norway

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Pfizer Investigational Site

Mosjøen, 8656, Norway

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Pfizer Investigational Site

Moss, 1502, Norway

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Pfizer Investigational Site

Mysen, 1850, Norway

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Pfizer Investigational Site

Nesttun, 5221, Norway

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Pfizer Investigational Site

Notodden, 3675, Norway

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Pfizer Investigational Site

Odda, 5750, Norway

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Pfizer Investigational Site

Oslo, 0027, Norway

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Pfizer Investigational Site

Oslo, 0160, Norway

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Pfizer Investigational Site

Oslo, 0264, Norway

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Pfizer Investigational Site

Oslo, 0303, Norway

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Pfizer Investigational Site

Oslo, 0407, Norway

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Pfizer Investigational Site

Oslo, 0456, Norway

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Pfizer Investigational Site

Oslo, 0514, Norway

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Pfizer Investigational Site

Oslo, 0913, Norway

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Pfizer Investigational Site

Paradis, 5231, Norway

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Pfizer Investigational Site

Porsgrunn, 3922, Norway

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Pfizer Investigational Site

Rud, 1309, Norway

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Pfizer Investigational Site

Sandvika, 1301, Norway

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Pfizer Investigational Site

Skedsmokorset, N-2020, Norway

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Pfizer Investigational Site

Ski, 1400, Norway

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Pfizer Investigational Site

Stavanger, 4004, Norway

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Pfizer Investigational Site

Stavanger, 4006, Norway

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Pfizer Investigational Site

Stavanger, 4023, Norway

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Pfizer Investigational Site

Stavanger, 4095, Norway

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Pfizer Investigational Site

Stord, 5400, Norway

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Pfizer Investigational Site

Tansberg, 3191, Norway

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Pfizer Investigational Site

Trondheim, 7001, Norway

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Pfizer Investigational Site

Trondheim, 7011, Norway

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Pfizer Investigational Site

Tynset, 2500, Norway

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Pfizer Investigational Site

Tønsberg, 3103, Norway

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Pfizer Investigational Site

Volda, 6100, Norway

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Pfizer Investigational Site

Alingsås, 441 83, Sweden

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Pfizer Investigational Site

Ängelholm, 262 81, Sweden

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Pfizer Investigational Site

Bålsta, 746 32, Sweden

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Pfizer Investigational Site

Borås, 501 82, Sweden

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Pfizer Investigational Site

Eksjö, 575 81, Sweden

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Pfizer Investigational Site

Eskilstuna, 631 88, Sweden

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Pfizer Investigational Site

Fagersta, 737 81, Sweden

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Pfizer Investigational Site

Falköping, 521 85, Sweden

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Pfizer Investigational Site

Falun, 791 82, Sweden

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Pfizer Investigational Site

Finspång, 612 25, Sweden

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Pfizer Investigational Site

Gateborg, 41345, Sweden

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Pfizer Investigational Site

Gävle, 800 02, Sweden

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Pfizer Investigational Site

Gävle, 801 87, Sweden

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Pfizer Investigational Site

Gävle, 802 57, Sweden

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Pfizer Investigational Site

Gävle, 802 84, Sweden

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Pfizer Investigational Site

Gothenburg, 413 45, Sweden

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Pfizer Investigational Site

Gothenburg, 417 17, Sweden

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Pfizer Investigational Site

Grästorp, 46722, Sweden

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Pfizer Investigational Site

Halmstad, 301 85, Sweden

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Pfizer Investigational Site

Hässleholm, 281 25, Sweden

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Pfizer Investigational Site

Hässleholm, 281 31, Sweden

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Pfizer Investigational Site

Helsingborg, 252 20, Sweden

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Pfizer Investigational Site

Helsingborg, 252 21, Sweden

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Pfizer Investigational Site

Hudiksvall, 824 81, Sweden

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Pfizer Investigational Site

Jönköping, 55185, Sweden

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Pfizer Investigational Site

Kalmar, 391 85, Sweden

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Pfizer Investigational Site

Karlshamn, 374 80, Sweden

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Pfizer Investigational Site

Karlskoga, S-691 81, Sweden

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Pfizer Investigational Site

Karlskrona, 371 85, Sweden

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Pfizer Investigational Site

Karlstad, 651 85, Sweden

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Pfizer Investigational Site

Katarineholm, 641 22, Sweden

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Pfizer Investigational Site

Köping, 731 80, Sweden

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Pfizer Investigational Site

Kristinehamn, 681 80, Sweden

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Pfizer Investigational Site

Lidköping, 531 85, Sweden

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Pfizer Investigational Site

Linka Ping, 581 85, Sweden

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Pfizer Investigational Site

Ljungby, 341 82, Sweden

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Pfizer Investigational Site

Ludvika, 771 81, Sweden

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Pfizer Investigational Site

Luleå, 971 80, Sweden

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Pfizer Investigational Site

Lycksele, 921 82, Sweden

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Pfizer Investigational Site

Malmo, 205 02, Sweden

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Pfizer Investigational Site

Malmo, 211 20, Sweden

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Pfizer Investigational Site

Malmo, 211 38, Sweden

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Pfizer Investigational Site

Malmo, 214 22, Sweden

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Pfizer Investigational Site

Mariestad, 542 24, Sweden

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Pfizer Investigational Site

Motala, 591 85, Sweden

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Pfizer Investigational Site

Mölndal, 431 80, Sweden

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Pfizer Investigational Site

Norrköping, 601 82, Sweden

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Pfizer Investigational Site

Sala, 733 25, Sweden

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Pfizer Investigational Site

Sandviken, 811 89, Sweden

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Pfizer Investigational Site

Skellefteå, 931 86, Sweden

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Pfizer Investigational Site

Skene, 511 81, Sweden

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Pfizer Investigational Site

Skövde, 541 85, Sweden

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Pfizer Investigational Site

Södertälje, 151 72, Sweden

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Pfizer Investigational Site

Stockholm, 111 35, Sweden

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Pfizer Investigational Site

Stockholm, 113 22, Sweden

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Pfizer Investigational Site

Stockholm, 113 82, Sweden

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Pfizer Investigational Site

Stockholm, 114 86, Sweden

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Pfizer Investigational Site

Stockholm, 116 25, Sweden

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Pfizer Investigational Site

Stockholm, 118 83, Sweden

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Pfizer Investigational Site

Strömstad, 452 83, Sweden

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Pfizer Investigational Site

Uddevalla, 451 80, Sweden

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Pfizer Investigational Site

Umeå, 901 85, Sweden

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Pfizer Investigational Site

Varberg, 432 81, Sweden

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Pfizer Investigational Site

Vänersborg, 46235, Sweden

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Pfizer Investigational Site

Västervik, 593 81, Sweden

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Pfizer Investigational Site

Location

Related Publications (9)

  • Pedersen TR, Faergeman O, Kastelein JJ, Olsson AG, Tikkanen MJ, Holme I, Larsen ML, Bendiksen FS, Lindahl C, Szarek M, Tsai J; Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) Study Group. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA. 2005 Nov 16;294(19):2437-45. doi: 10.1001/jama.294.19.2437.

  • Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

  • 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.

  • 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.

  • Stoekenbroek RM, Boekholdt SM, Fayyad R, Laskey R, Tikkanen MJ, Pedersen TR, Hovingh GK; Incremental Decrease in End Points Through Aggressive Lipid Lowering Study Group. High-dose atorvastatin is superior to moderate-dose simvastatin in preventing peripheral arterial disease. Heart. 2015 Mar;101(5):356-62. doi: 10.1136/heartjnl-2014-306906. Epub 2015 Jan 16.

  • 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.

  • 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.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

AtorvastatinSimvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

February 1, 1999

Study Completion

March 1, 2005

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations