ILLUMINATE: A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease
Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00134264
Collaborator
(none)
15,067
221
35
68.2
1.9
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
15067 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official 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
Study Start Date
:
Jul 1, 2004
Actual Primary Completion Date
:
Jun 1, 2007
Actual Study Completion Date
:
Jun 1, 2007
Outcome Measures
Primary Outcome Measures
- The time to first occurrence of a major cardiovascular disease event []
Secondary Outcome Measures
- Various composites of major cardiovascular disease events and other lipid parameters []
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Alabaster | Alabama | United States | |
| 2 | Pfizer Investigational Site | Birmingham | Alabama | United States | |
| 3 | Pfizer Investigational Site | Gilbert | Arizona | United States | |
| 4 | Pfizer Investigational Site | Phoenix | Arizona | United States | |
| 5 | Pfizer Investigational Site | Tucson | Arizona | United States | |
| 6 | Pfizer Investigational Site | Fresno | California | United States | |
| 7 | Pfizer Investigational Site | Los Angeles | California | United States | |
| 8 | Pfizer Investigational Site | Modesto | California | United States | |
| 9 | Pfizer Investigational Site | San Diego | California | United States | |
| 10 | Pfizer Investigational Site | Santa Rosa | California | United States | |
| 11 | Pfizer Investigational Site | Tustin | California | United States | |
| 12 | Pfizer Investigational Site | Walnut Creek | California | United States | |
| 13 | Pfizer Investigational Site | Denver | Colorado | United States | |
| 14 | Pfizer Investigational Site | Longmont | Colorado | United States | |
| 15 | Pfizer Investigational Site | Guilford | Connecticut | United States | |
| 16 | Pfizer Investigational Site | Hartford | Connecticut | United States | |
| 17 | Pfizer Investigational Site | Washington | District of Columbia | United States | |
| 18 | Pfizer Investigational Site | Clearwater | Florida | United States | |
| 19 | Pfizer Investigational Site | Coral Gables | Florida | United States | |
| 20 | Pfizer Investigational Site | Fort Meyers | Florida | United States | |
| 21 | Pfizer Investigational Site | Jacksonville Beach | Florida | United States | |
| 22 | Pfizer Investigational Site | Jacksonville | Florida | United States | |
| 23 | Pfizer Investigational Site | Lakeland | Florida | United States | |
| 24 | Pfizer Investigational Site | Orlando | Florida | United States | |
| 25 | Pfizer Investigational Site | Pensacola | Florida | United States | |
| 26 | Pfizer Investigational Site | Port Charlotte | Florida | United States | |
| 27 | Pfizer Investigational Site | Sarasota | Florida | United States | |
| 28 | Pfizer Investigational Site | West Palm Beach | Florida | United States | |
| 29 | Pfizer Investigational Site | Atlanta | Georgia | United States | |
| 30 | Pfizer Investigational Site | Aurora | Illinois | United States | |
| 31 | Pfizer Investigational Site | Blue Island | Illinois | United States | |
| 32 | Pfizer Investigational Site | Chicago | Illinois | United States | |
| 33 | Pfizer Investigational Site | Evansville | Indiana | United States | |
| 34 | Pfizer Investigational Site | Fort Wayne | Indiana | United States | |
| 35 | Pfizer Investigational Site | Davenport | Iowa | United States | |
| 36 | Pfizer Investigational Site | des Moines | Iowa | United States | |
| 37 | Pfizer Investigational Site | Iowa City | Iowa | United States | |
| 38 | Pfizer Investigational Site | Wichita | Kansas | United States | |
| 39 | Pfizer Investigational Site | Witchita | Kansas | United States | |
| 40 | Pfizer Investigational Site | Louisville | Kentucky | United States | |
| 41 | Pfizer Investigational Site | Baton Rouge | Louisiana | United States | |
| 42 | Pfizer Investigational Site | Covington | Louisiana | United States | |
| 43 | Pfizer Investigational Site | Marrero | Louisiana | United States | |
| 44 | Pfizer Investigational Site | Scarborough | Maine | United States | |
| 45 | Pfizer Investigational Site | Baltimore | Maryland | United States | |
| 46 | Pfizer Investigational Site | Bel Air | Maryland | United States | |
| 47 | Pfizer Investigational Site | Columbia | Maryland | United States | |
| 48 | Pfizer Investigational Site | Towson | Maryland | United States | |
| 49 | Pfizer Investigational Site | Westminster | Maryland | United States | |
| 50 | Pfizer Investigational Site | Abington | Massachusetts | United States | |
| 51 | Pfizer Investigational Site | Haverhill | Massachusetts | United States | |
| 52 | Pfizer Investigational Site | Natick | Massachusetts | United States | |
| 53 | Pfizer Investigational Site | Grand Rapids | Michigan | United States | |
| 54 | Pfizer Investigational Site | Minneapolis | Minnesota | United States | |
| 55 | Pfizer Investigational Site | St. Paul | Minnesota | United States | |
| 56 | Pfizer Investigational Site | St. Louis | Missouri | United States | |
| 57 | Pfizer Investigational Site | Billings | Montana | United States | |
| 58 | Pfizer Investigational Site | Butte | Montana | United States | |
| 59 | Pfizer Investigational Site | Omaha | Nebraska | United States | |
| 60 | Pfizer Investigational Site | Papillon | Nebraska | United States | |
| 61 | Pfizer Investigational Site | Las Vegas | Nevada | United States | |
| 62 | Pfizer Investigational Site | Concord | New Hampshire | United States | |
| 63 | Pfizer Investigational Site | Lebanon | New Hampshire | United States | |
| 64 | Pfizer Investigational Site | Manchester | New Hampshire | United States | |
| 65 | Pfizer Investigational Site | Elmer | New Jersey | United States | |
| 66 | Pfizer Investigational Site | Haddon Heights | New Jersey | United States | |
| 67 | Pfizer Investigational Site | New Brunswick | New Jersey | United States | |
| 68 | Pfizer Investigational Site | Garden City | New York | United States | |
| 69 | Pfizer Investigational Site | New Hyde Park | New York | United States | |
| 70 | Pfizer Investigational Site | Rochester | New York | United States | |
| 71 | Pfizer Investigational Site | Durham | North Carolina | United States | |
| 72 | Pfizer Investigational Site | Winston-salem | North Carolina | United States | |
| 73 | Pfizer Investigational Site | Cincinnati | Ohio | United States | |
| 74 | Pfizer Investigational Site | Cleveland | Ohio | United States | |
| 75 | Pfizer Investigational Site | Columbus | Ohio | United States | |
| 76 | Pfizer Investigational Site | Mansfield | Ohio | United States | |
| 77 | Pfizer Investigational Site | Sandusky | Ohio | United States | |
| 78 | Pfizer Investigational Site | Toledo | Ohio | United States | |
| 79 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | |
| 80 | Pfizer Investigational Site | Portland | Oregon | United States | |
| 81 | Pfizer Investigational Site | Beaver | Pennsylvania | United States | |
| 82 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | |
| 83 | Pfizer Investigational Site | Kingsport | Tennessee | United States | |
| 84 | Pfizer Investigational Site | Nashville | Tennessee | United States | |
| 85 | Pfizer Investigational Site | Beaumont | Texas | United States | |
| 86 | Pfizer Investigational Site | Dallas | Texas | United States | |
| 87 | Pfizer Investigational Site | Houston | Texas | United States | |
| 88 | Pfizer Investigational Site | Plano | Texas | United States | |
| 89 | Pfizer Investigational Site | San Antonio | Texas | United States | |
| 90 | Pfizer Investigational Site | Salt Lake City | Utah | United States | |
| 91 | Pfizer Investigational Site | Burlington | Vermont | United States | |
| 92 | Pfizer Investigational Site | Norfolk | Virginia | United States | |
| 93 | Pfizer Investigational Site | Richmond | Virginia | United States | |
| 94 | Pfizer Investigational Site | Burien | Washington | United States | |
| 95 | Pfizer Investigational Site | Tacoma | Washington | United States | |
| 96 | Pfizer Investigational Site | Concord | New South Wales | Australia | |
| 97 | Pfizer Investigational Site | East Gosford | New South Wales | Australia | |
| 98 | Pfizer Investigational Site | St. Leonards | New South Wales | Australia | |
| 99 | Pfizer Investigational Site | Wollongong | New South Wales | Australia | |
| 100 | Pfizer Investigational Site | Chermside | Queensland | Australia | |
| 101 | Pfizer Investigational Site | Herston | Queensland | Australia | |
| 102 | Pfizer Investigational Site | Woolloongabba | Queensland | Australia | |
| 103 | Pfizer Investigational Site | Adelaide | South Australia | Australia | |
| 104 | Pfizer Investigational Site | Bedford Park | South Australia | Australia | |
| 105 | Pfizer Investigational Site | Woodville | South Australia | Australia | |
| 106 | Pfizer Investigational Site | Clayton | Victoria | Australia | |
| 107 | Pfizer Investigational Site | Fitzroy | Victoria | Australia | |
| 108 | Pfizer Investigational Site | Footscray | Victoria | Australia | |
| 109 | Pfizer Investigational Site | Heidelberg | Victoria | Australia | |
| 110 | Pfizer Investigational Site | Prahran | Victoria | Australia | |
| 111 | Pfizer Investigational Site | Fremantle | Western Australia | Australia | |
| 112 | Pfizer Investigational Site | Joondalup | Western Australia | Australia | |
| 113 | Pfizer Investigational Site | Camperdown | Australia | ||
| 114 | Pfizer Investigational Site | Darlinghurst | Australia | ||
| 115 | Pfizer Investigational Site | Geelong | Australia | ||
| 116 | Pfizer Investigational Site | Launceston, Tas | Australia | ||
| 117 | Pfizer Investigational Site | Melbourne | Australia | ||
| 118 | Pfizer Investigational Site | Nedlands | Australia | ||
| 119 | Pfizer Investigational Site | Perth | Australia | ||
| 120 | Pfizer Investigational Site | Southport | Australia | ||
| 121 | Pfizer Investigational Site | Calgary | Alberta | Canada | |
| 122 | Pfizer Investigational Site | Vancouver | British Columbia | Canada | |
| 123 | Pfizer Investigational Site | Winnipeg | Manitoba | Canada | |
| 124 | Pfizer Investigational Site | Halifax | Nova Scotia | Canada | |
| 125 | Pfizer Investigational Site | Cornwall | Ontario | Canada | |
| 126 | Pfizer Investigational Site | Newmarket | Ontario | Canada | |
| 127 | Pfizer Investigational Site | Oshawa | Ontario | Canada | |
| 128 | Pfizer Investigational Site | Sarnia | Ontario | Canada | |
| 129 | Pfizer Investigational Site | Scarborough | Ontario | Canada | |
| 130 | Pfizer Investigational Site | Toronto | Ontario | Canada | |
| 131 | Pfizer Investigational Site | Laval | Quebec | Canada | |
| 132 | Pfizer Investigational Site | Montreal | Quebec | Canada | |
| 133 | Pfizer Investigational Site | Sainte-foy | Quebec | Canada | |
| 134 | Pfizer Investigational Site | Sherbrooke | Quebec | Canada | |
| 135 | Pfizer Investigational Site | Ste-foy | Quebec | Canada | |
| 136 | Pfizer Investigational Site | Saint John's | Canada | ||
| 137 | Pfizer Investigational Site | Amsterdam | Netherlands | ||
| 138 | Pfizer Investigational Site | AN Rotterdam | Netherlands | ||
| 139 | Pfizer Investigational Site | Apeldoorn | Netherlands | ||
| 140 | Pfizer Investigational Site | Arnhem | Netherlands | ||
| 141 | Pfizer Investigational Site | Breda | Netherlands | ||
| 142 | Pfizer Investigational Site | Cappelle aan den IJssel | Netherlands | ||
| 143 | Pfizer Investigational Site | Delft | Netherlands | ||
| 144 | Pfizer Investigational Site | Eindhoven | Netherlands | ||
| 145 | Pfizer Investigational Site | Goes | Netherlands | ||
| 146 | Pfizer Investigational Site | Gouda | Netherlands | ||
| 147 | Pfizer Investigational Site | Groningen | Netherlands | ||
| 148 | Pfizer Investigational Site | Heerlen | Netherlands | ||
| 149 | Pfizer Investigational Site | Hertogenbosch | Netherlands | ||
| 150 | Pfizer Investigational Site | Hoorn | Netherlands | ||
| 151 | Pfizer Investigational Site | Leiden | Netherlands | ||
| 152 | Pfizer Investigational Site | Maastricht | Netherlands | ||
| 153 | Pfizer Investigational Site | Nijmegen | Netherlands | ||
| 154 | Pfizer Investigational Site | Rotterdam | Netherlands | ||
| 155 | Pfizer Investigational Site | Sittard | Netherlands | ||
| 156 | Pfizer Investigational Site | Utrecht | Netherlands | ||
| 157 | Pfizer Investigational Site | Velp | Netherlands | ||
| 158 | Pfizer Investigational Site | Venlo | Netherlands | ||
| 159 | Pfizer Investigational Site | Zoetermeer | Netherlands | ||
| 160 | Pfizer Investigational Site | Sant Coloma de Gramenet | Barcelona | Spain | |
| 161 | Pfizer Investigational Site | Terrasa | Barcelona | Spain | |
| 162 | Pfizer Investigational Site | Jerez de La Frontera | Cadiz | Spain | |
| 163 | Pfizer Investigational Site | Santander | Cantabria | Spain | |
| 164 | Pfizer Investigational Site | San Sebastian | Guipuzcoa | Spain | |
| 165 | Pfizer Investigational Site | Ferrol | La Coruna | Spain | |
| 166 | Pfizer Investigational Site | Santiago De Compostela | La Coruña | Spain | |
| 167 | Pfizer Investigational Site | Almeria | Spain | ||
| 168 | Pfizer Investigational Site | Barcelona | Spain | ||
| 169 | Pfizer Investigational Site | Ciudad Real | Spain | ||
| 170 | Pfizer Investigational Site | Granada | Spain | ||
| 171 | Pfizer Investigational Site | Madrid | Spain | ||
| 172 | Pfizer Investigational Site | Malaga | Spain | ||
| 173 | Pfizer Investigational Site | Salamanca | Spain | ||
| 174 | Pfizer Investigational Site | Sevilla | Spain | ||
| 175 | Pfizer Investigational Site | Valencia | Spain | ||
| 176 | Pfizer Investigational Site | Zaragoza | Spain | ||
| 177 | Pfizer Investigational Site | Borås | Sweden | ||
| 178 | Pfizer Investigational Site | Eskilstuna | Sweden | ||
| 179 | Pfizer Investigational Site | Goteborg | Sweden | ||
| 180 | Pfizer Investigational Site | Göteborg | Sweden | ||
| 181 | Pfizer Investigational Site | Helsingborg | Sweden | ||
| 182 | Pfizer Investigational Site | Hässleholm | Sweden | ||
| 183 | Pfizer Investigational Site | Karlshamn | Sweden | ||
| 184 | Pfizer Investigational Site | Koping | Sweden | ||
| 185 | Pfizer Investigational Site | Linköping | Sweden | ||
| 186 | Pfizer Investigational Site | Lulea | Sweden | ||
| 187 | Pfizer Investigational Site | Lund | Sweden | ||
| 188 | Pfizer Investigational Site | Malmo | Sweden | ||
| 189 | Pfizer Investigational Site | Molndal | Sweden | ||
| 190 | Pfizer Investigational Site | Norrkoping | Sweden | ||
| 191 | Pfizer Investigational Site | Ostersund | Sweden | ||
| 192 | Pfizer Investigational Site | Skelleftea | Sweden | ||
| 193 | Pfizer Investigational Site | Stockholm | Sweden | ||
| 194 | Pfizer Investigational Site | Uddevalla | Sweden | ||
| 195 | Pfizer Investigational Site | Uppsala | Sweden | ||
| 196 | Pfizer Investigational Site | Vaxjo | Sweden | ||
| 197 | Pfizer Investigational Site | Västervik | Sweden | ||
| 198 | Pfizer Investigational Site | Wrexham | Clwyd | United Kingdom | |
| 199 | Pfizer Investigational Site | Woolwich | London | United Kingdom | |
| 200 | Pfizer Investigational Site | Glasgow | Scotland | United Kingdom | |
| 201 | Pfizer Investigational Site | Aberdeen | United Kingdom | ||
| 202 | Pfizer Investigational Site | Bath | United Kingdom | ||
| 203 | Pfizer Investigational Site | Birmingham | United Kingdom | ||
| 204 | Pfizer Investigational Site | Bournemouth | United Kingdom | ||
| 205 | Pfizer Investigational Site | Brighton, East Sussex | United Kingdom | ||
| 206 | Pfizer Investigational Site | Bristol | United Kingdom | ||
| 207 | Pfizer Investigational Site | Cardiff | United Kingdom | ||
| 208 | Pfizer Investigational Site | Chichester | United Kingdom | ||
| 209 | Pfizer Investigational Site | Coventry | United Kingdom | ||
| 210 | Pfizer Investigational Site | Dundee | United Kingdom | ||
| 211 | Pfizer Investigational Site | Edinburgh | United Kingdom | ||
| 212 | Pfizer Investigational Site | Exeter | United Kingdom | ||
| 213 | Pfizer Investigational Site | Glasgow | United Kingdom | ||
| 214 | Pfizer Investigational Site | Harrow | United Kingdom | ||
| 215 | Pfizer Investigational Site | Leicester | United Kingdom | ||
| 216 | Pfizer Investigational Site | Liverpool | United Kingdom | ||
| 217 | Pfizer Investigational Site | London | United Kingdom | ||
| 218 | Pfizer Investigational Site | Newcastle-upon-Tyne | United Kingdom | ||
| 219 | Pfizer Investigational Site | Romford | United Kingdom | ||
| 220 | Pfizer Investigational Site | Shrewsbury | United Kingdom | ||
| 221 | Pfizer Investigational Site | Warwick | United Kingdom |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00134264
Other Study ID Numbers:
- A5091043
First Posted:
Aug 24, 2005
Last Update Posted:
Feb 3, 2012
Last Verified:
Jan 1, 2012