En undersøgelse, der undersøgte Torcetrapib/Atorvastatin og Atorvastatins virkninger på kliniske CV-hændelser hos patienter med hjertesygdom (ILLUMINATE)
30. januar 2012 opdateret af: Pfizer
Fase 3 multicenter, dobbeltblind, randomiseret, parallel gruppeevaluering af den faste kombination Torcetrapib/Atorvastatin, administreret oralt, én gang dagligt (Qd), sammenlignet med atorvastatin alene, ved forekomsten af større kardiovaskulære hændelser hos personer med koronar hjertesygdom eller risiko Tilsvarende
Torcetrapib-projektet blev afsluttet den 2. december 2006 på grund af sikkerhedsfund.
For at demonstrere, om torcetrapib/atorvastatin kan reducere risikoen for alvorlige hjertekarsygdomme, sammenlignet med atorvastatin alene, hos patienter med koronar hjertesygdom eller risikoækvivalenter
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15067
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Camperdown, Australien
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Darlinghurst, Australien
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Geelong, Australien
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Launceston, Tas, Australien
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Melbourne, Australien
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Nedlands, Australien
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Perth, Australien
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Southport, Australien
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New South Wales
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Concord, New South Wales, Australien
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East Gosford, New South Wales, Australien
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St. Leonards, New South Wales, Australien
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Wollongong, New South Wales, Australien
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Queensland
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Chermside, Queensland, Australien
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Herston, Queensland, Australien
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Woolloongabba, Queensland, Australien
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South Australia
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Adelaide, South Australia, Australien
- Pfizer Investigational Site
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Bedford Park, South Australia, Australien
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Woodville, South Australia, Australien
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Victoria
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Clayton, Victoria, Australien
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Fitzroy, Victoria, Australien
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Footscray, Victoria, Australien
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Heidelberg, Victoria, Australien
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Prahran, Victoria, Australien
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Western Australia
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Fremantle, Western Australia, Australien
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Joondalup, Western Australia, Australien
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Saint John's, Canada
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Alberta
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Calgary, Alberta, Canada
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British Columbia
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Vancouver, British Columbia, Canada
- Pfizer Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canada
- Pfizer Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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Cornwall, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Sarnia, Ontario, Canada
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Scarborough, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Sainte-foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Ste-foy, Quebec, Canada
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Aberdeen, Det Forenede Kongerige
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Bath, Det Forenede Kongerige
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Birmingham, Det Forenede Kongerige
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Bournemouth, Det Forenede Kongerige
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Brighton, East Sussex, Det Forenede Kongerige
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Bristol, Det Forenede Kongerige
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Cardiff, Det Forenede Kongerige
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Chichester, Det Forenede Kongerige
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Coventry, Det Forenede Kongerige
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Dundee, Det Forenede Kongerige
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Edinburgh, Det Forenede Kongerige
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Exeter, Det Forenede Kongerige
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Glasgow, Det Forenede Kongerige
- Pfizer Investigational Site
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Harrow, Det Forenede Kongerige
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Leicester, Det Forenede Kongerige
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Liverpool, Det Forenede Kongerige
- Pfizer Investigational Site
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London, Det Forenede Kongerige
- Pfizer Investigational Site
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Newcastle-upon-Tyne, Det Forenede Kongerige
- Pfizer Investigational Site
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Romford, Det Forenede Kongerige
- Pfizer Investigational Site
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Shrewsbury, Det Forenede Kongerige
- Pfizer Investigational Site
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Warwick, Det Forenede Kongerige
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Clwyd
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Wrexham, Clwyd, Det Forenede Kongerige
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London
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Woolwich, London, Det Forenede Kongerige
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Scotland
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Glasgow, Scotland, Det Forenede Kongerige
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Alabama
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Alabaster, Alabama, Forenede Stater
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Birmingham, Alabama, Forenede Stater
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Arizona
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Gilbert, Arizona, Forenede Stater
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Phoenix, Arizona, Forenede Stater
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Tucson, Arizona, Forenede Stater
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California
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Fresno, California, Forenede Stater
- Pfizer Investigational Site
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Los Angeles, California, Forenede Stater
- Pfizer Investigational Site
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Modesto, California, Forenede Stater
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San Diego, California, Forenede Stater
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Santa Rosa, California, Forenede Stater
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Tustin, California, Forenede Stater
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Walnut Creek, California, Forenede Stater
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Colorado
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Denver, Colorado, Forenede Stater
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Longmont, Colorado, Forenede Stater
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Connecticut
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Guilford, Connecticut, Forenede Stater
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Hartford, Connecticut, Forenede Stater
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District of Columbia
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Washington, District of Columbia, Forenede Stater
- Pfizer Investigational Site
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Florida
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Clearwater, Florida, Forenede Stater
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Coral Gables, Florida, Forenede Stater
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Fort Meyers, Florida, Forenede Stater
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Jacksonville, Florida, Forenede Stater
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Jacksonville Beach, Florida, Forenede Stater
- Pfizer Investigational Site
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Lakeland, Florida, Forenede Stater
- Pfizer Investigational Site
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Orlando, Florida, Forenede Stater
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Pensacola, Florida, Forenede Stater
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Port Charlotte, Florida, Forenede Stater
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Sarasota, Florida, Forenede Stater
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West Palm Beach, Florida, Forenede Stater
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Georgia
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Atlanta, Georgia, Forenede Stater
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Illinois
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Aurora, Illinois, Forenede Stater
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Blue Island, Illinois, Forenede Stater
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Chicago, Illinois, Forenede Stater
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Indiana
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Evansville, Indiana, Forenede Stater
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Fort Wayne, Indiana, Forenede Stater
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Iowa
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Davenport, Iowa, Forenede Stater
- Pfizer Investigational Site
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Iowa City, Iowa, Forenede Stater
- Pfizer Investigational Site
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des Moines, Iowa, Forenede Stater
- Pfizer Investigational Site
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Kansas
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Wichita, Kansas, Forenede Stater
- Pfizer Investigational Site
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Witchita, Kansas, Forenede Stater
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Kentucky
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Louisville, Kentucky, Forenede Stater
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater
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Covington, Louisiana, Forenede Stater
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Marrero, Louisiana, Forenede Stater
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Maine
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Scarborough, Maine, Forenede Stater
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Maryland
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Baltimore, Maryland, Forenede Stater
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Bel Air, Maryland, Forenede Stater
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Columbia, Maryland, Forenede Stater
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Towson, Maryland, Forenede Stater
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Westminster, Maryland, Forenede Stater
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Massachusetts
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Abington, Massachusetts, Forenede Stater
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Haverhill, Massachusetts, Forenede Stater
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Natick, Massachusetts, Forenede Stater
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Michigan
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Grand Rapids, Michigan, Forenede Stater
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Minnesota
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Minneapolis, Minnesota, Forenede Stater
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St. Paul, Minnesota, Forenede Stater
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Missouri
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St. Louis, Missouri, Forenede Stater
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Montana
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Billings, Montana, Forenede Stater
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Butte, Montana, Forenede Stater
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Nebraska
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Omaha, Nebraska, Forenede Stater
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Papillon, Nebraska, Forenede Stater
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Nevada
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Las Vegas, Nevada, Forenede Stater
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New Hampshire
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Concord, New Hampshire, Forenede Stater
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Lebanon, New Hampshire, Forenede Stater
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Manchester, New Hampshire, Forenede Stater
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New Jersey
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Elmer, New Jersey, Forenede Stater
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Haddon Heights, New Jersey, Forenede Stater
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New Brunswick, New Jersey, Forenede Stater
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New York
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Garden City, New York, Forenede Stater
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New Hyde Park, New York, Forenede Stater
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Rochester, New York, Forenede Stater
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North Carolina
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Durham, North Carolina, Forenede Stater
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Winston-salem, North Carolina, Forenede Stater
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Ohio
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Cincinnati, Ohio, Forenede Stater
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Cleveland, Ohio, Forenede Stater
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Columbus, Ohio, Forenede Stater
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Mansfield, Ohio, Forenede Stater
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Sandusky, Ohio, Forenede Stater
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Toledo, Ohio, Forenede Stater
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater
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Oregon
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Portland, Oregon, Forenede Stater
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Pennsylvania
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Beaver, Pennsylvania, Forenede Stater
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Philadelphia, Pennsylvania, Forenede Stater
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Tennessee
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Kingsport, Tennessee, Forenede Stater
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Nashville, Tennessee, Forenede Stater
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Texas
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Beaumont, Texas, Forenede Stater
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Dallas, Texas, Forenede Stater
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Houston, Texas, Forenede Stater
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Plano, Texas, Forenede Stater
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San Antonio, Texas, Forenede Stater
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Utah
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Salt Lake City, Utah, Forenede Stater
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Vermont
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Burlington, Vermont, Forenede Stater
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Virginia
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Norfolk, Virginia, Forenede Stater
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Richmond, Virginia, Forenede Stater
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Washington
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Burien, Washington, Forenede Stater
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Tacoma, Washington, Forenede Stater
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AN Rotterdam, Holland
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Amsterdam, Holland
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Apeldoorn, Holland
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Arnhem, Holland
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Breda, Holland
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Cappelle aan den IJssel, Holland
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Delft, Holland
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Eindhoven, Holland
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Goes, Holland
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Gouda, Holland
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Groningen, Holland
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Heerlen, Holland
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Hertogenbosch, Holland
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Hoorn, Holland
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Leiden, Holland
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Maastricht, Holland
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Nijmegen, Holland
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Rotterdam, Holland
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Sittard, Holland
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Utrecht, Holland
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Velp, Holland
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Venlo, Holland
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Zoetermeer, Holland
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Almeria, Spanien
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Barcelona, Spanien
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Ciudad Real, Spanien
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Granada, Spanien
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Madrid, Spanien
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Malaga, Spanien
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Salamanca, Spanien
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Sevilla, Spanien
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Valencia, Spanien
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Zaragoza, Spanien
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Barcelona
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Sant Coloma de Gramenet, Barcelona, Spanien
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Terrasa, Barcelona, Spanien
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Cadiz
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Jerez de La Frontera, Cadiz, Spanien
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Cantabria
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Santander, Cantabria, Spanien
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Guipuzcoa
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San Sebastian, Guipuzcoa, Spanien
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La Coruna
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Ferrol, La Coruna, Spanien
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La Coruña
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Santiago De Compostela, La Coruña, Spanien
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Borås, Sverige
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Eskilstuna, Sverige
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Goteborg, Sverige
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Göteborg, Sverige
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Helsingborg, Sverige
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Hässleholm, Sverige
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Karlshamn, Sverige
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Koping, Sverige
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Linköping, Sverige
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Lulea, Sverige
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Lund, Sverige
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Malmo, Sverige
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Molndal, Sverige
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Norrkoping, Sverige
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Ostersund, Sverige
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Skelleftea, Sverige
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Stockholm, Sverige
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Uddevalla, Sverige
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Uppsala, Sverige
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Vaxjo, Sverige
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Västervik, Sverige
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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
45 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Diagnose af koronar hjertesygdom eller risikoækvivalenter, der placerer patienten i høj risiko for hjertekarsygdomme
Ekskluderingskriterier:
- Kvinder, der er gravide eller ammer, eller som planlægger at blive gravide.
- Personer med et klinisk indiceret behov for statin (HMG-CoA-reduktasehæmmer) behandling, bortset fra atorvastatin eller anden samtidig behandling med kendte lipidændrende effekter på LDL-C og HDL-C, herunder fibrater og nikotinsyre
- Personer, der tager medicin, der vides at være forbundet med en øget risiko for myositis i kombination med HMG-CoA-reduktasehæmmere
- Forsøgspersoner med enhver anden medicinsk tilstand eller laboratorieabnormitet, som kunne påvirke forsøgspersonens sikkerhed, udelukke evaluering af respons eller gøre det usandsynligt, at forsøgspersonen ville fuldføre undersøgelsen
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Tiden til den første forekomst af en alvorlig hjertekarsygdomsbegivenhed
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Sekundære resultatmål
Resultatmål |
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Forskellige sammensætninger af større kardiovaskulære sygdomsbegivenheder og andre lipidparametre
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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
- Arsenault BJ, Petrides F, Tabet F, Bao W, Hovingh GK, Boekholdt SM, Ramin-Mangata S, Meilhac O, DeMicco D, Rye KA, Waters DD, Kastelein JJP, Barter P, Lambert G. Effect of atorvastatin, cholesterol ester transfer protein inhibition, and diabetes mellitus on circulating proprotein subtilisin kexin type 9 and lipoprotein(a) levels in patients at high cardiovascular risk. J Clin Lipidol. 2018 Jan-Feb;12(1):130-136. doi: 10.1016/j.jacl.2017.10.001. Epub 2017 Oct 12.
- Williams SA, Murthy AC, DeLisle RK, Hyde C, Malarstig A, Ostroff R, Weiss SJ, Segal MR, Ganz P. Improving Assessment of Drug Safety Through Proteomics: Early Detection and Mechanistic Characterization of the Unforeseen Harmful Effects of Torcetrapib. Circulation. 2018 Mar 6;137(10):999-1010. doi: 10.1161/CIRCULATIONAHA.117.028213. Epub 2017 Oct 3.
- Bagdade J, Barter P, Quiroga C, Alaupovic P. Effects of Torcetrapib and Statin Treatment on ApoC-III and Apoprotein-Defined Lipoprotein Subclasses (from the ILLUMINATE Trial). Am J Cardiol. 2017 Jun 1;119(11):1753-1756. doi: 10.1016/j.amjcard.2017.02.049. Epub 2017 Mar 18.
- Barter PJ, Rye KA, Tardif JC, Waters DD, Boekholdt SM, Breazna A, Kastelein JJ. Effect of torcetrapib on glucose, insulin, and hemoglobin A1c in subjects in the Investigation of Lipid Level Management to Understand its Impact in Atherosclerotic Events (ILLUMINATE) trial. Circulation. 2011 Aug 2;124(5):555-62. doi: 10.1161/CIRCULATIONAHA.111.018259. Epub 2011 Jul 18.
- Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and Radiance 2 Study Groups. Ultrasound protocols to measure carotid intima-media thickness in trials; comparison of reproducibility, rate of progression, and effect of intervention in subjects with familial hypercholesterolemia and subjects with mixed dyslipidemia. Ann Med. 2010 Sep;42(6):447-64. doi: 10.3109/07853890.2010.499132.
- Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and 2 Study Groups. Completeness of carotid intima media thickness measurements depends on body composition: the RADIANCE 1 and 2 trials. J Atheroscler Thromb. 2010 May;17(5):526-35. doi: 10.5551/jat.3269. Epub 2010 Mar 13.
- Vergeer M, Bots ML, van Leuven SI, Basart DC, Sijbrands EJ, Evans GW, Grobbee DE, Visseren FL, Stalenhoef AF, Stroes ES, Kastelein JJ. Cholesteryl ester transfer protein inhibitor torcetrapib and off-target toxicity: a pooled analysis of the rating atherosclerotic disease change by imaging with a new CETP inhibitor (RADIANCE) trials. Circulation. 2008 Dec 9;118(24):2515-22. doi: 10.1161/CIRCULATIONAHA.108.772665. Epub 2008 Nov 24. Erratum In: Circulation. 2009 Feb 10;119(5):e197.
- Barter PJ, Caulfield M, Eriksson M, Grundy SM, Kastelein JJ, Komajda M, Lopez-Sendon J, Mosca L, Tardif JC, Waters DD, Shear CL, Revkin JH, Buhr KA, Fisher MR, Tall AR, Brewer B; ILLUMINATE Investigators. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med. 2007 Nov 22;357(21):2109-22. doi: 10.1056/NEJMoa0706628. Epub 2007 Nov 5.
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. juli 2004
Primær færdiggørelse (Faktiske)
1. juni 2007
Studieafslutning (Faktiske)
1. juni 2007
Datoer for studieregistrering
Først indsendt
22. august 2005
Først indsendt, der opfyldte QC-kriterier
22. august 2005
Først opslået (Skøn)
24. august 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. februar 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. januar 2012
Sidst verificeret
1. januar 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A5091043
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