Cardiovascular Diseases Clinical Trial
— IDEALOfficial title:
Atorvastatin Compared With Simvastatin In The Prevention of CHD Morbidity And Mortality In Patients With CHD
| Verified date | April 2015 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Norway: Norwegian Medicines Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 8600 |
| Est. completion date | March 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 80 Years |
| Eligibility |
Inclusion Criteria: - Previous myocardial infarction Exclusion Criteria: - Women who are breast feeding or are pregnant |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Pfizer Investigational Site | Arhus C | |
| Denmark | Pfizer Investigational Site | Copenhagen | |
| Denmark | Pfizer Investigational Site | Esbjerg | |
| Denmark | Pfizer Investigational Site | Fredericia | |
| Denmark | Pfizer Investigational Site | Frederiksberg | |
| Denmark | Pfizer Investigational Site | Frederikssund | |
| Denmark | Pfizer Investigational Site | Grena | |
| Denmark | Pfizer Investigational Site | Helsingoer | |
| Denmark | Pfizer Investigational Site | Hjorring | |
| Denmark | Pfizer Investigational Site | Holbak | |
| Denmark | Pfizer Investigational Site | Holstebro | |
| Denmark | Pfizer Investigational Site | Hvidovre | |
| Denmark | Pfizer Investigational Site | København NV | |
| Denmark | Pfizer Investigational Site | Kabenhavn S | |
| Denmark | Pfizer Investigational Site | Kalundborg | |
| Denmark | Pfizer Investigational Site | Kobenhavn K | |
| Denmark | Pfizer Investigational Site | Kobenhavn Nv | |
| Denmark | Pfizer Investigational Site | Koge | |
| Denmark | Pfizer Investigational Site | Middelfart | |
| Denmark | Pfizer Investigational Site | Naestved | |
| Denmark | Pfizer Investigational Site | Nykobing F | |
| Denmark | Pfizer Investigational Site | Odder | |
| Denmark | Pfizer Investigational Site | Randers | |
| Denmark | Pfizer Investigational Site | Roskilde | |
| Denmark | Pfizer Investigational Site | Silkeborg | |
| Denmark | Pfizer Investigational Site | Skive | |
| Denmark | Pfizer Investigational Site | Slagelse | |
| Denmark | Pfizer Investigational Site | Svendborg | |
| Finland | Pfizer Investigational Site | Heinola | |
| Finland | Pfizer Investigational Site | Helsinki | |
| Finland | Pfizer Investigational Site | Helsinki | |
| Finland | Pfizer Investigational Site | Joensuu | |
| Finland | Pfizer Investigational Site | Jyvaskyla | |
| Finland | Pfizer Investigational Site | Kerava | |
| Finland | Pfizer Investigational Site | Kuopio | |
| Finland | Pfizer Investigational Site | Lahti | |
| Finland | Pfizer Investigational Site | Lappeenranta | |
| Finland | Pfizer Investigational Site | Lohja | |
| Finland | Pfizer Investigational Site | Mikkeli | |
| Finland | Pfizer Investigational Site | Rauma | |
| Finland | Pfizer Investigational Site | Salo | |
| Finland | Pfizer Investigational Site | Siaraalamaki | |
| Finland | Pfizer Investigational Site | Tammisaari | |
| Finland | Pfizer Investigational Site | Tampere | |
| Finland | Pfizer Investigational Site | Vantaa | |
| Iceland | Pfizer Investigational Site | Reykjavik | |
| Iceland | Pfizer Investigational Site | Reykjavik | |
| Netherlands | Pfizer Investigational Site | 's-Hertogenbosch | |
| Netherlands | Pfizer Investigational Site | Alkmaar | |
| Netherlands | Pfizer Investigational Site | Amsterdam | |
| Netherlands | Pfizer Investigational Site | Assen | |
| Netherlands | Pfizer Investigational Site | Breda | |
| Netherlands | Pfizer Investigational Site | Capelle Aan Den Ijssel | |
| Netherlands | Pfizer Investigational Site | Delft | |
| Netherlands | Pfizer Investigational Site | Deventer | |
| Netherlands | Pfizer Investigational Site | EDE | |
| Netherlands | Pfizer Investigational Site | Eindhoven | |
| Netherlands | Pfizer Investigational Site | Enschede | |
| Netherlands | Pfizer Investigational Site | Goes | |
| Netherlands | Pfizer Investigational Site | Groningen | |
| Netherlands | Pfizer Investigational Site | Hoorn | |
| Netherlands | Pfizer Investigational Site | Nijmegen | |
| Netherlands | Pfizer Investigational Site | Oss | |
| Netherlands | Pfizer Investigational Site | Rotterdam | |
| Netherlands | Pfizer Investigational Site | Tilburg | |
| Netherlands | Pfizer Investigational Site | Tilurg | |
| Netherlands | Pfizer Investigational Site | Utrecht | |
| Netherlands | Pfizer Investigational Site | Weert | |
| Netherlands | Pfizer Investigational Site | Zwijndrecht | |
| Netherlands | Pfizer Investigational Site | Zwolle | |
| Norway | Pfizer Investigational Site | Alesund | |
| Norway | Pfizer Investigational Site | Alesund | |
| Norway | Pfizer Investigational Site | Bergen | |
| Norway | Pfizer Investigational Site | Bergen | |
| Norway | Pfizer Investigational Site | Bergen | |
| Norway | Pfizer Investigational Site | Bergen | |
| Norway | Pfizer Investigational Site | Bergen | |
| Norway | Pfizer Investigational Site | Bodo | |
| Norway | Pfizer Investigational Site | Flekkefjord | |
| Norway | Pfizer Investigational Site | Forde | |
| Norway | Pfizer Investigational Site | Hammerfest | |
| Norway | Pfizer Investigational Site | Haugesund | |
| Norway | Pfizer Investigational Site | Hobøl | |
| Norway | Pfizer Investigational Site | Jessheim | |
| Norway | Pfizer Investigational Site | Karasjok | |
| Norway | Pfizer Investigational Site | Kongsberg | |
| Norway | Pfizer Investigational Site | Kongsvinger | |
| Norway | Pfizer Investigational Site | Kragero | |
| Norway | Pfizer Investigational Site | Kristiansand | |
| Norway | Pfizer Investigational Site | Kristiansund N | |
| Norway | Pfizer Investigational Site | Larvik | |
| Norway | Pfizer Investigational Site | Levanger | |
| Norway | Pfizer Investigational Site | Lillestom | |
| Norway | Pfizer Investigational Site | Lorenskog | |
| Norway | Pfizer Investigational Site | Mo I Rana | |
| Norway | Pfizer Investigational Site | Molde | |
| Norway | Pfizer Investigational Site | Molde | |
| Norway | Pfizer Investigational Site | Mosjøen | |
| Norway | Pfizer Investigational Site | Moss | |
| Norway | Pfizer Investigational Site | Mysen | |
| Norway | Pfizer Investigational Site | Nesttun | |
| Norway | Pfizer Investigational Site | Notodden | |
| Norway | Pfizer Investigational Site | Odda | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Paradis | |
| Norway | Pfizer Investigational Site | Porsgrunn | |
| Norway | Pfizer Investigational Site | Rud | |
| Norway | Pfizer Investigational Site | Sandvika | |
| Norway | Pfizer Investigational Site | Skedsmokorset | |
| Norway | Pfizer Investigational Site | Ski | |
| Norway | Pfizer Investigational Site | Stavanger | |
| Norway | Pfizer Investigational Site | Stavanger | |
| Norway | Pfizer Investigational Site | Stavanger | |
| Norway | Pfizer Investigational Site | Stavanger | |
| Norway | Pfizer Investigational Site | Stord | |
| Norway | Pfizer Investigational Site | Tansberg | |
| Norway | Pfizer Investigational Site | Tonsberg | |
| Norway | Pfizer Investigational Site | Trondheim | |
| Norway | Pfizer Investigational Site | Trondheim | |
| Norway | Pfizer Investigational Site | Tynset | |
| Norway | Pfizer Investigational Site | Volda | |
| Sweden | Pfizer Investigational Site | Alingsas | |
| Sweden | Pfizer Investigational Site | Angelholm | |
| Sweden | Pfizer Investigational Site | Balsta | |
| Sweden | Pfizer Investigational Site | Boras | |
| Sweden | Pfizer Investigational Site | Eksjo | |
| Sweden | Pfizer Investigational Site | Eskilstuna | |
| Sweden | Pfizer Investigational Site | Fagersta | |
| Sweden | Pfizer Investigational Site | Falkoping | |
| Sweden | Pfizer Investigational Site | Falun | |
| Sweden | Pfizer Investigational Site | Finspang | |
| Sweden | Pfizer Investigational Site | Gateborg | |
| Sweden | Pfizer Investigational Site | Gavle | |
| Sweden | Pfizer Investigational Site | Gavle | |
| Sweden | Pfizer Investigational Site | Gavle | |
| Sweden | Pfizer Investigational Site | Gavle | |
| Sweden | Pfizer Investigational Site | Goteborg | |
| Sweden | Pfizer Investigational Site | Gothenburg | |
| Sweden | Pfizer Investigational Site | Grastorp | |
| Sweden | Pfizer Investigational Site | Halmstad | |
| Sweden | Pfizer Investigational Site | Hassleholm | |
| Sweden | Pfizer Investigational Site | Hassleholm | |
| Sweden | Pfizer Investigational Site | Helsingborg | |
| Sweden | Pfizer Investigational Site | Helsingborg | |
| Sweden | Pfizer Investigational Site | Hudiksvall | |
| Sweden | Pfizer Investigational Site | Jonkoping | |
| Sweden | Pfizer Investigational Site | Kalmar | |
| Sweden | Pfizer Investigational Site | Karlshamn | |
| Sweden | Pfizer Investigational Site | Karlskoga | |
| Sweden | Pfizer Investigational Site | Karlskrona | |
| Sweden | Pfizer Investigational Site | Karlstad | |
| Sweden | Pfizer Investigational Site | Katarineholm | |
| Sweden | Pfizer Investigational Site | Koping | |
| Sweden | Pfizer Investigational Site | Kristinehamn | |
| Sweden | Pfizer Investigational Site | Lidkoping | |
| Sweden | Pfizer Investigational Site | Linka Ping | |
| Sweden | Pfizer Investigational Site | Ljungby | |
| Sweden | Pfizer Investigational Site | Ludvika | |
| Sweden | Pfizer Investigational Site | Lulea | |
| Sweden | Pfizer Investigational Site | Lycksele | |
| Sweden | Pfizer Investigational Site | Malmo | |
| Sweden | Pfizer Investigational Site | Malmo | |
| Sweden | Pfizer Investigational Site | Malmo | |
| Sweden | Pfizer Investigational Site | Malmo | |
| Sweden | Pfizer Investigational Site | Mariestad | |
| Sweden | Pfizer Investigational Site | Molndal | |
| Sweden | Pfizer Investigational Site | Motala | |
| Sweden | Pfizer Investigational Site | Norrkoping | |
| Sweden | Pfizer Investigational Site | Sala | |
| Sweden | Pfizer Investigational Site | Sandviken | |
| Sweden | Pfizer Investigational Site | Skelleftea | |
| Sweden | Pfizer Investigational Site | Skene | |
| Sweden | Pfizer Investigational Site | Skovde | |
| Sweden | Pfizer Investigational Site | Sodertalje | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Stromstad | |
| Sweden | Pfizer Investigational Site | Uddevalla | |
| Sweden | Pfizer Investigational Site | Umea | |
| Sweden | Pfizer Investigational Site | Unknown | |
| Sweden | Pfizer Investigational Site | Vänersborg | |
| Sweden | Pfizer Investigational Site | Varberg | |
| Sweden | Pfizer Investigational Site | Vastervik |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Denmark, Finland, Iceland, Netherlands, Norway, Sweden,
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 s — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to of a major coronary event: 1) non-fatal acute myocardial infarction 2) coronary death 3) resuscitated cardiac arrest | |||
| Secondary | 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 |
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