Diabetes Mellitus Clinical Trial
— ILLUMINATEOfficial title:
Phase 3 Multi Center, Double Blind, Randomized, Parallel Group Evaluation Of The Fixed Combination Torcetrapib/Atorvastatin, Administered Orally, Once Daily (Qd), Compared With Atorvastatin Alone, On The Occurrence Of Major Cardiovascular Events In Subjects With Coronary Heart Disease Or Risk Equivalents
| Verified date | January 2012 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular
disease events, when compared to atorvastatin alone, in patients with coronary heart disease
or risk equivalents
| Status | Terminated |
| Enrollment | 15067 |
| Est. completion date | June 2007 |
| Est. primary completion date | June 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events Exclusion Criteria: - Women who are pregnant or lactating, or planning to become pregnant. - Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid - Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors - Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Pfizer Investigational Site | Adelaide | South Australia |
| Australia | Pfizer Investigational Site | Bedford Park | South Australia |
| Australia | Pfizer Investigational Site | Camperdown | |
| Australia | Pfizer Investigational Site | Chermside | Queensland |
| Australia | Pfizer Investigational Site | Clayton | Victoria |
| Australia | Pfizer Investigational Site | Concord | New South Wales |
| Australia | Pfizer Investigational Site | Darlinghurst | |
| Australia | Pfizer Investigational Site | East Gosford | New South Wales |
| Australia | Pfizer Investigational Site | Fitzroy | Victoria |
| Australia | Pfizer Investigational Site | Footscray | Victoria |
| Australia | Pfizer Investigational Site | Fremantle | Western Australia |
| Australia | Pfizer Investigational Site | Geelong | |
| Australia | Pfizer Investigational Site | Heidelberg | Victoria |
| Australia | Pfizer Investigational Site | Herston | Queensland |
| Australia | Pfizer Investigational Site | Joondalup | Western Australia |
| Australia | Pfizer Investigational Site | Launceston, Tas | |
| Australia | Pfizer Investigational Site | Melbourne | |
| Australia | Pfizer Investigational Site | Nedlands | |
| Australia | Pfizer Investigational Site | Perth | |
| Australia | Pfizer Investigational Site | Prahran | Victoria |
| Australia | Pfizer Investigational Site | Southport | |
| Australia | Pfizer Investigational Site | St. Leonards | New South Wales |
| Australia | Pfizer Investigational Site | Wollongong | New South Wales |
| Australia | Pfizer Investigational Site | Woodville | South Australia |
| Australia | Pfizer Investigational Site | Woolloongabba | Queensland |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Cornwall | Ontario |
| Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
| Canada | Pfizer Investigational Site | Laval | Quebec |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Newmarket | Ontario |
| Canada | Pfizer Investigational Site | Oshawa | Ontario |
| Canada | Pfizer Investigational Site | Saint John's | |
| Canada | Pfizer Investigational Site | Sainte-foy | Quebec |
| Canada | Pfizer Investigational Site | Sarnia | Ontario |
| Canada | Pfizer Investigational Site | Scarborough | Ontario |
| Canada | Pfizer Investigational Site | Sherbrooke | Quebec |
| Canada | Pfizer Investigational Site | Ste-foy | Quebec |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
| Netherlands | Pfizer Investigational Site | Amsterdam | |
| Netherlands | Pfizer Investigational Site | AN Rotterdam | |
| Netherlands | Pfizer Investigational Site | Apeldoorn | |
| Netherlands | Pfizer Investigational Site | Arnhem | |
| Netherlands | Pfizer Investigational Site | Breda | |
| Netherlands | Pfizer Investigational Site | Cappelle aan den IJssel | |
| Netherlands | Pfizer Investigational Site | Delft | |
| Netherlands | Pfizer Investigational Site | Eindhoven | |
| Netherlands | Pfizer Investigational Site | Goes | |
| Netherlands | Pfizer Investigational Site | Gouda | |
| Netherlands | Pfizer Investigational Site | Groningen | |
| Netherlands | Pfizer Investigational Site | Heerlen | |
| Netherlands | Pfizer Investigational Site | Hertogenbosch | |
| Netherlands | Pfizer Investigational Site | Hoorn | |
| Netherlands | Pfizer Investigational Site | Leiden | |
| Netherlands | Pfizer Investigational Site | Maastricht | |
| Netherlands | Pfizer Investigational Site | Nijmegen | |
| Netherlands | Pfizer Investigational Site | Rotterdam | |
| Netherlands | Pfizer Investigational Site | Sittard | |
| Netherlands | Pfizer Investigational Site | Utrecht | |
| Netherlands | Pfizer Investigational Site | Velp | |
| Netherlands | Pfizer Investigational Site | Venlo | |
| Netherlands | Pfizer Investigational Site | Zoetermeer | |
| Spain | Pfizer Investigational Site | Almeria | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Ciudad Real | |
| Spain | Pfizer Investigational Site | Ferrol | La Coruna |
| Spain | Pfizer Investigational Site | Granada | |
| Spain | Pfizer Investigational Site | Jerez de La Frontera | Cadiz |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Malaga | |
| Spain | Pfizer Investigational Site | Salamanca | |
| Spain | Pfizer Investigational Site | San Sebastian | Guipuzcoa |
| Spain | Pfizer Investigational Site | Sant Coloma de Gramenet | Barcelona |
| Spain | Pfizer Investigational Site | Santander | Cantabria |
| Spain | Pfizer Investigational Site | Santiago De Compostela | La Coruña |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Terrasa | Barcelona |
| Spain | Pfizer Investigational Site | Valencia | |
| Spain | Pfizer Investigational Site | Zaragoza | |
| Sweden | Pfizer Investigational Site | Borås | |
| Sweden | Pfizer Investigational Site | Eskilstuna | |
| Sweden | Pfizer Investigational Site | Goteborg | |
| Sweden | Pfizer Investigational Site | Göteborg | |
| Sweden | Pfizer Investigational Site | Hässleholm | |
| Sweden | Pfizer Investigational Site | Helsingborg | |
| Sweden | Pfizer Investigational Site | Karlshamn | |
| Sweden | Pfizer Investigational Site | Koping | |
| Sweden | Pfizer Investigational Site | Linköping | |
| Sweden | Pfizer Investigational Site | Lulea | |
| Sweden | Pfizer Investigational Site | Lund | |
| Sweden | Pfizer Investigational Site | Malmo | |
| Sweden | Pfizer Investigational Site | Molndal | |
| Sweden | Pfizer Investigational Site | Norrkoping | |
| Sweden | Pfizer Investigational Site | Ostersund | |
| Sweden | Pfizer Investigational Site | Skelleftea | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Uddevalla | |
| Sweden | Pfizer Investigational Site | Uppsala | |
| Sweden | Pfizer Investigational Site | Västervik | |
| Sweden | Pfizer Investigational Site | Vaxjo | |
| United Kingdom | Pfizer Investigational Site | Aberdeen | |
| United Kingdom | Pfizer Investigational Site | Bath | |
| United Kingdom | Pfizer Investigational Site | Birmingham | |
| United Kingdom | Pfizer Investigational Site | Bournemouth | |
| United Kingdom | Pfizer Investigational Site | Brighton, East Sussex | |
| United Kingdom | Pfizer Investigational Site | Bristol | |
| United Kingdom | Pfizer Investigational Site | Cardiff | |
| United Kingdom | Pfizer Investigational Site | Chichester | |
| United Kingdom | Pfizer Investigational Site | Coventry | |
| United Kingdom | Pfizer Investigational Site | Dundee | |
| United Kingdom | Pfizer Investigational Site | Edinburgh | |
| United Kingdom | Pfizer Investigational Site | Exeter | |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Glasgow | Scotland |
| United Kingdom | Pfizer Investigational Site | Harrow | |
| United Kingdom | Pfizer Investigational Site | Leicester | |
| United Kingdom | Pfizer Investigational Site | Liverpool | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | Newcastle-upon-Tyne | |
| United Kingdom | Pfizer Investigational Site | Romford | |
| United Kingdom | Pfizer Investigational Site | Shrewsbury | |
| United Kingdom | Pfizer Investigational Site | Warwick | |
| United Kingdom | Pfizer Investigational Site | Woolwich | London |
| United Kingdom | Pfizer Investigational Site | Wrexham | Clwyd |
| United States | Pfizer Investigational Site | Abington | Massachusetts |
| United States | Pfizer Investigational Site | Alabaster | Alabama |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Aurora | Illinois |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baton Rouge | Louisiana |
| United States | Pfizer Investigational Site | Beaumont | Texas |
| United States | Pfizer Investigational Site | Beaver | Pennsylvania |
| United States | Pfizer Investigational Site | Bel Air | Maryland |
| United States | Pfizer Investigational Site | Billings | Montana |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Blue Island | Illinois |
| United States | Pfizer Investigational Site | Burien | Washington |
| United States | Pfizer Investigational Site | Burlington | Vermont |
| United States | Pfizer Investigational Site | Butte | Montana |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Clearwater | Florida |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Columbia | Maryland |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Concord | New Hampshire |
| United States | Pfizer Investigational Site | Coral Gables | Florida |
| United States | Pfizer Investigational Site | Covington | Louisiana |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Davenport | Iowa |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | des Moines | Iowa |
| United States | Pfizer Investigational Site | Durham | North Carolina |
| United States | Pfizer Investigational Site | Elmer | New Jersey |
| United States | Pfizer Investigational Site | Evansville | Indiana |
| United States | Pfizer Investigational Site | Fort Meyers | Florida |
| United States | Pfizer Investigational Site | Fort Wayne | Indiana |
| United States | Pfizer Investigational Site | Fresno | California |
| United States | Pfizer Investigational Site | Garden City | New York |
| United States | Pfizer Investigational Site | Gilbert | Arizona |
| United States | Pfizer Investigational Site | Grand Rapids | Michigan |
| United States | Pfizer Investigational Site | Guilford | Connecticut |
| United States | Pfizer Investigational Site | Haddon Heights | New Jersey |
| United States | Pfizer Investigational Site | Hartford | Connecticut |
| United States | Pfizer Investigational Site | Haverhill | Massachusetts |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Iowa City | Iowa |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Jacksonville Beach | Florida |
| United States | Pfizer Investigational Site | Kingsport | Tennessee |
| United States | Pfizer Investigational Site | Lakeland | Florida |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Lebanon | New Hampshire |
| United States | Pfizer Investigational Site | Longmont | Colorado |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Manchester | New Hampshire |
| United States | Pfizer Investigational Site | Mansfield | Ohio |
| United States | Pfizer Investigational Site | Marrero | Louisiana |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Modesto | California |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | Natick | Massachusetts |
| United States | Pfizer Investigational Site | New Brunswick | New Jersey |
| United States | Pfizer Investigational Site | New Hyde Park | New York |
| United States | Pfizer Investigational Site | Norfolk | Virginia |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Orlando | Florida |
| United States | Pfizer Investigational Site | Papillon | Nebraska |
| United States | Pfizer Investigational Site | Pensacola | Florida |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Plano | Texas |
| United States | Pfizer Investigational Site | Port Charlotte | Florida |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Sandusky | Ohio |
| United States | Pfizer Investigational Site | Santa Rosa | California |
| United States | Pfizer Investigational Site | Sarasota | Florida |
| United States | Pfizer Investigational Site | Scarborough | Maine |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Paul | Minnesota |
| United States | Pfizer Investigational Site | Tacoma | Washington |
| United States | Pfizer Investigational Site | Toledo | Ohio |
| United States | Pfizer Investigational Site | Towson | Maryland |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Tustin | California |
| United States | Pfizer Investigational Site | Walnut Creek | California |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| United States | Pfizer Investigational Site | Westminster | Maryland |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Winston-salem | North Carolina |
| United States | Pfizer Investigational Site | Witchita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Canada, Netherlands, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The time to first occurrence of a major cardiovascular disease event | |||
| Secondary | Various composites of major cardiovascular disease events and other lipid parameters |
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