Atorvastatin Versus Simvastatin In The Prevention Of Coronary Heart Disease (CHD) In Patients With Known CHD (IDEAL)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159835
First received: September 8, 2005
Last updated: September 22, 2009
Last verified: May 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Diseases |
Drug: atorvastatin Drug: simvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Atorvastatin Compared With Simvastatin In The Prevention of CHD Morbidity And Mortality In Patients With CHD |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Time to of a major coronary event: 1) non-fatal acute myocardial infarction 2) coronary death 3) resuscitated cardiac arrest
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 8600 |
| Study Start Date: | February 1999 |
| Estimated Study Completion Date: | March 2005 |
Eligibility| Ages Eligible for Study: | up to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Previous myocardial infarction
Exclusion Criteria:
- Women who are breast feeding or are pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159835
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| Denmark | |
| Pfizer Investigational Site | |
| Arhus C, Denmark, DK-8000 | |
| Pfizer Investigational Site | |
| Copenhagen, Denmark, 2100 | |
| Pfizer Investigational Site | |
| Esbjerg, Denmark, 6700 | |
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| Fredericia, Denmark, 7000 | |
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| Frederiksberg, Denmark, 2000 | |
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| Frederikssund, Denmark, 3600 | |
| Pfizer Investigational Site | |
| Grena, Denmark, 8500 | |
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| Helsingoer, Denmark, 3000 | |
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| Hjorring, Denmark, 9800 | |
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| Holbak, Denmark, 4300 | |
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| Holstebro, Denmark, 7500 | |
| Pfizer Investigational Site | |
| Hvidovre, Denmark, 2650 | |
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| Kabenhavn S, Denmark, 2300 | |
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| Kalundborg, Denmark, 4400 | |
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| Kobenhavn K, Denmark, 1256 | |
| Pfizer Investigational Site | |
| Kobenhavn Nv, Denmark, 2400 | |
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| Koge, Denmark, 4600 | |
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| København NV, Denmark, 2400 | |
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| Middelfart, Denmark, 5500 | |
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| Naestved, Denmark, 4700 | |
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| Nykobing F, Denmark, 4800 | |
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| Odder, Denmark, 8300 | |
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| Randers, Denmark, 8900 | |
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| Roskilde, Denmark, 4000 | |
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| Silkeborg, Denmark, 8600 | |
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| Skive, Denmark, 7800 | |
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| Slagelse, Denmark, 4200 | |
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| Svendborg, Denmark, 5700 | |
| Finland | |
| Pfizer Investigational Site | |
| Heinola, Finland, 18100 | |
| Pfizer Investigational Site | |
| Helsinki, Finland, 00100 | |
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| Helsinki, Finland, 00029 | |
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| Joensuu, Finland, 80210 | |
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| Jyvaskyla, Finland, 40100 | |
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| Kerava, Finland, 04200 | |
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| Kuopio, Finland, 70210 | |
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| Lahti, Finland, 15110 | |
| Pfizer Investigational Site | |
| Lappeenranta, Finland, 53130 | |
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| Lohja, Finland, 08200 | |
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| Mikkeli, Finland, 50100 | |
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| Rauma, Finland, 26100 | |
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| Salo, Finland, 24130 | |
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| Siaraalamaki, Finland, 45750 | |
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| Tammisaari, Finland, 10600 | |
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| Tampere, Finland, 33520 | |
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| Vantaa, Finland, 01400 | |
| Iceland | |
| Pfizer Investigational Site | |
| Reykjavik, Iceland, 101 | |
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| Reykjavik, Iceland, 108 | |
| Netherlands | |
| Pfizer Investigational Site | |
| 's-Hertogenbosch, Netherlands, 5211 NL | |
| Pfizer Investigational Site | |
| Alkmaar, Netherlands, 1815 JD | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands, 1061 AE | |
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| Assen, Netherlands, 9401 RK | |
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| Breda, Netherlands, 4818 CK | |
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| Capelle Aan Den Ijssel, Netherlands, 2906 ZC | |
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| Delft, Netherlands, 2625 AD | |
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| Deventer, Netherlands, 7415 CM | |
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| EDE, Netherlands, 6716 RP | |
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| Eindhoven, Netherlands, 5623 EJ | |
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| Enschede, Netherlands, 7511 JX | |
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| Goes, Netherlands, 4462 RA | |
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| Groningen, Netherlands, 9721 SW | |
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| Hoorn, Netherlands, 1624 GM | |
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| Nijmegen, Netherlands, 6532 SZ | |
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| Oss, Netherlands, NL-5342 BT | |
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| Rotterdam, Netherlands, 3045 PM | |
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| Tilburg, Netherlands, 5022 GC | |
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| Tilurg, Netherlands, 5022 GC | |
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| Utrecht, Netherlands, NL-3508-TG | |
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| Weert, Netherlands, 6001 BE | |
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| Zwijndrecht, Netherlands, 3331 LZ | |
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| Zwolle, Netherlands, 8011 JW | |
| Norway | |
| Pfizer Investigational Site | |
| 8092 Bodo, Norway, 8092 | |
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| Alesund, Norway, 6002 | |
| Pfizer Investigational Site | |
| Alesund, Norway, 6026 | |
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| Bergen, Norway, 5009 | |
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| Bergen, Norway, 5021 | |
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| Bergen, Norway, 5008 | |
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| Bergen, Norway, 5015 | |
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| Bergen, Norway, 5012 | |
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| Flekkefjord, Norway, 4400 | |
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| Forde, Norway, 6807 | |
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| Hammerfest, Norway, 9613 | |
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| Haugesund, Norway, 5500 | |
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| Hobøl, Norway, 1827 | |
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| Jessheim, Norway, 2050 | |
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| Karasjok, Norway, 9735 | |
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| Kongsberg, Norway, 3600 | |
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| Kongsvinger, Norway, 2226 | |
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| Kragero, Norway, 3770 | |
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| Kristiansand, Norway, 4612 | |
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| Kristiansund N, Norway, 6508 | |
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| Larvik, Norway, 3257 | |
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| Levanger, Norway, 7600 | |
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| Lillestom, Norway, 2000 | |
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| Lorenskog, Norway, 1478 | |
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| Mo I Rana, Norway, 8607 | |
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| Molde, Norway, 6407 | |
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| Molde, Norway, 6415 | |
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| Mosjøen, Norway, 8656 | |
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| Moss, Norway, 1502 | |
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| Mysen, Norway, 1850 | |
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| Nesttun, Norway, 5221 | |
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| Notodden, Norway, 3675 | |
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| Odda, Norway, 5750 | |
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| Oslo, Norway, 0913 | |
| Pfizer Investigational Site | |
| Oslo, Norway, 0456 | |
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| Oslo, Norway, 0027 | |
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| Oslo, Norway, 0160 | |
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| Oslo, Norway, 0514 | |
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| Oslo, Norway, 0264 | |
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| Oslo, Norway, 0303 | |
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| Oslo, Norway, 0407 | |
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| Paradis, Norway, 5231 | |
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| Porsgrunn, Norway, 3922 | |
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| Rud, Norway, 1309 | |
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| Sandvika, Norway, 1301 | |
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| Skedsmokorset, Norway, N-2020 | |
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| Ski, Norway, 1400 | |
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| Stavanger, Norway, 4023 | |
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| Stavanger, Norway, 4004 | |
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| Stavanger, Norway, 4006 | |
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| Stavanger, Norway, 4095 | |
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| Stord, Norway, 5400 | |
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| Tansberg, Norway, 3191 | |
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| Tonsberg, Norway, 3103 | |
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| Trondheim, Norway, 7011 | |
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| Trondheim, Norway, 7001 | |
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| Tynset, Norway, 2500 | |
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| Volda, Norway, 6100 | |
| Sweden | |
| Pfizer Investigational Site | |
| Alingsas, Sweden, 441 83 | |
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| Angelholm, Sweden, 262 81 | |
| Pfizer Investigational Site | |
| Balsta, Sweden, 746 32 | |
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| Boras, Sweden, 501 82 | |
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| Eksjo, Sweden, 575 81 | |
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| Eskilstuna, Sweden, 631 88 | |
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| Fagersta, Sweden, 737 81 | |
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| Falkoping, Sweden, 521 85 | |
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| Falun, Sweden, 791 82 | |
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| Finspang, Sweden, 612 25 | |
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| Gateborg, Sweden, 41345 | |
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| Gavle, Sweden, 802 57 | |
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| Gavle, Sweden, 801 87 | |
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| Gavle, Sweden, 802 84 | |
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| Gavle, Sweden, 800 02 | |
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| Goteborg, Sweden, 413 45 | |
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| Gothenburg, Sweden, 417 17 | |
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| Grastorp, Sweden, 46722 | |
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| Halmstad, Sweden, 301 85 | |
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| Hassleholm, Sweden, 281 25 | |
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| Hassleholm, Sweden, 281 31 | |
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| Helsingborg, Sweden, 252 21 | |
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| Helsingborg, Sweden, 252 20 | |
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| Hudiksvall, Sweden, 824 81 | |
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| Jonkoping, Sweden, 55185 | |
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| Kalmar, Sweden, 391 85 | |
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| Karlshamn, Sweden, 374 80 | |
| Pfizer Investigational Site | |
| Karlskoga, Sweden, S-691 81 | |
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| Karlskrona, Sweden, 371 85 | |
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| Karlstad, Sweden, 651 85 | |
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| Katarineholm, Sweden, 641 22 | |
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| Koping, Sweden, 731 80 | |
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| Kristinehamn, Sweden, 681 80 | |
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| Lidkoping, Sweden, 531 85 | |
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| Linka Ping, Sweden, 581 85 | |
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| Ljungby, Sweden, 341 82 | |
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| Ludvika, Sweden, 771 81 | |
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| Lulea, Sweden, 971 80 | |
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| Lycksele, Sweden, 921 82 | |
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| Malmo, Sweden, 205 02 | |
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| Malmo, Sweden, 214 22 | |
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| Malmo, Sweden, 211 20 | |
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| Malmo, Sweden, 211 38 | |
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| Mariestad, Sweden, 542 24 | |
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| Molndal, Sweden, 431 80 | |
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| Motala, Sweden, 591 85 | |
| Pfizer Investigational Site | |
| Norrkoping, Sweden, 601 82 | |
| Pfizer Investigational Site | |
| Sala, Sweden, 733 25 | |
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| Sandviken, Sweden, 811 89 | |
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| Skelleftea, Sweden, 931 86 | |
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| Skene, Sweden, 511 81 | |
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| Skovde, Sweden, 541 85 | |
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| Sodertalje, Sweden, 151 72 | |
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| Stockholm, Sweden, 118 83 | |
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| Stockholm, Sweden, 114 86 | |
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| Stockholm, Sweden, 113 22 | |
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| Stockholm, Sweden, 113 82 | |
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| Stockholm, Sweden, 116 25 | |
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| Stockholm, Sweden, 111 35 | |
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| Stromstad, Sweden, 452 83 | |
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| Uddevalla, Sweden, 451 80 | |
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| Umea, Sweden, 901 85 | |
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| Unknown, Sweden | |
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| Varberg, Sweden, 432 81 | |
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| Vastervik, Sweden, 593 81 | |
| Pfizer Investigational Site | |
| Vänersborg, Sweden, 46235 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00159835 History of Changes |
| Other Study ID Numbers: | ATV-N-98-001, A2581145 |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 22, 2009 |
| Health Authority: | Norway: Norwegian Medicines Agency |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Disease Myocardial Ischemia Heart Diseases Vascular Diseases Simvastatin Atorvastatin Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013