ILLUSTRATE: A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00134173
Collaborator
(none)
1,100
147
35
7.5
0.2
Study Details
Study Description
Brief Summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To look at ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
For additional information please call: 1-800-718-1021
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Angiographically Documented Coronary Heart Disease.
Study Start Date
:
Oct 1, 2003
Actual Study Completion Date
:
Sep 1, 2006
Outcome Measures
Primary Outcome Measures
- Change coronary artery atheroma volume as measured by intravascular ultrasound. []
Secondary Outcome Measures
- Changes in levels of lipids and other biomarkers. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- angiographic evidence of coronary atherosclerosis
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 evaluation of 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 | Birmingham | Alabama | United States | |
| 2 | Pfizer Investigational Site | Mobile | Alabama | United States | |
| 3 | Pfizer Investigational Site | Little Rock | Arkansas | United States | |
| 4 | Pfizer Investigational Site | Fresno | California | United States | |
| 5 | Pfizer Investigational Site | Los Altos | California | United States | |
| 6 | Pfizer Investigational Site | Los Angeles | California | United States | |
| 7 | Pfizer Investigational Site | Mountain View | California | United States | |
| 8 | Pfizer Investigational Site | Sacramento | California | United States | |
| 9 | Pfizer Investigational Site | San Diego | California | United States | |
| 10 | Pfizer Investigational Site | San Francisco | California | United States | |
| 11 | Pfizer Investigational Site | Santa Rosa | California | United States | |
| 12 | Pfizer Investigational Site | Stockton | California | United States | |
| 13 | Pfizer Investigational Site | Boulder | Colorado | United States | |
| 14 | Pfizer Investigational Site | Denver | Colorado | United States | |
| 15 | Pfizer Investigational Site | Brandford | Connecticut | United States | |
| 16 | Pfizer Investigational Site | Farmington | Connecticut | United States | |
| 17 | Pfizer Investigational Site | Guilford | Connecticut | United States | |
| 18 | Pfizer Investigational Site | New Haven | Connecticut | United States | |
| 19 | Pfizer Investigational Site | Atlantis | Florida | United States | |
| 20 | Pfizer Investigational Site | Clearwater | Florida | United States | |
| 21 | Pfizer Investigational Site | Dunedin | Florida | United States | |
| 22 | Pfizer Investigational Site | Fort Lauderdale | Florida | United States | |
| 23 | Pfizer Investigational Site | Jacksonville | Florida | United States | |
| 24 | Pfizer Investigational Site | Largo | Florida | United States | |
| 25 | Pfizer Investigational Site | Melbourne | Florida | United States | |
| 26 | Pfizer Investigational Site | Miami | Florida | United States | |
| 27 | Pfizer Investigational Site | Orlando | Florida | United States | |
| 28 | Pfizer Investigational Site | Pensacola | Florida | United States | |
| 29 | Pfizer Investigational Site | Safety Harbor | Florida | United States | |
| 30 | Pfizer Investigational Site | Sarasota | Florida | United States | |
| 31 | Pfizer Investigational Site | Tampa | Florida | United States | |
| 32 | Pfizer Investigational Site | Blue Island | Illinois | United States | |
| 33 | Pfizer Investigational Site | Merrionette Park | Illinois | United States | |
| 34 | Pfizer Investigational Site | Rockford | Illinois | United States | |
| 35 | Pfizer Investigational Site | Elkhart | Indiana | United States | |
| 36 | Pfizer Investigational Site | Goshen | Indiana | United States | |
| 37 | Pfizer Investigational Site | Hobart | Indiana | United States | |
| 38 | Pfizer Investigational Site | Merrillville | Indiana | United States | |
| 39 | Pfizer Investigational Site | Davenport | Iowa | United States | |
| 40 | Pfizer Investigational Site | Des Moines | Iowa | United States | |
| 41 | Pfizer Investigational Site | West Des Moines | Iowa | United States | |
| 42 | Pfizer Investigational Site | Shawnee Mission | Kansas | United States | |
| 43 | Pfizer Investigational Site | Louisville | Kentucky | United States | |
| 44 | Pfizer Investigational Site | Bogalusa | Louisiana | United States | |
| 45 | Pfizer Investigational Site | Covington | Louisiana | United States | |
| 46 | Pfizer Investigational Site | New Orleans | Louisiana | United States | |
| 47 | Pfizer Investigational Site | Auburn | Maine | United States | |
| 48 | Pfizer Investigational Site | Lewiston | Maine | United States | |
| 49 | Pfizer Investigational Site | Portland | Maine | United States | |
| 50 | Pfizer Investigational Site | Scarborough | Maine | United States | |
| 51 | Pfizer Investigational Site | Baltimore | Maryland | United States | |
| 52 | Pfizer Investigational Site | Columbia | Maryland | United States | |
| 53 | Pfizer Investigational Site | Salisbury | Maryland | United States | |
| 54 | Pfizer Investigational Site | Takoma Park | Maryland | United States | |
| 55 | Pfizer Investigational Site | Ann Arbor | Michigan | United States | |
| 56 | Pfizer Investigational Site | Flint | Michigan | United States | |
| 57 | Pfizer Investigational Site | Kalamazoo | Michigan | United States | |
| 58 | Pfizer Investigational Site | Lapeer | Michigan | United States | |
| 59 | Pfizer Investigational Site | Petoskey | Michigan | United States | |
| 60 | Pfizer Investigational Site | Royal Oak | Michigan | United States | |
| 61 | Pfizer Investigational Site | Saginaw | Michigan | United States | |
| 62 | Pfizer Investigational Site | Ypsilanti | Michigan | United States | |
| 63 | Pfizer Investigational Site | Duluth | Minnesota | United States | |
| 64 | Pfizer Investigational Site | Maplewood | Minnesota | United States | |
| 65 | Pfizer Investigational Site | Minneapolis | Minnesota | United States | |
| 66 | Pfizer Investigational Site | St. Cloud | Minnesota | United States | |
| 67 | Pfizer Investigational Site | St. Paul | Minnesota | United States | |
| 68 | Pfizer Investigational Site | Southaven | Mississippi | United States | |
| 69 | Pfizer Investigational Site | Kansas City | Missouri | United States | |
| 70 | Pfizer Investigational Site | Omaha | Nebraska | United States | |
| 71 | Pfizer Investigational Site | Ridgewood | New Jersey | United States | |
| 72 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | |
| 73 | Pfizer Investigational Site | Carlsbad | New Mexico | United States | |
| 74 | Pfizer Investigational Site | Albany | New York | United States | |
| 75 | Pfizer Investigational Site | Bay Shore | New York | United States | |
| 76 | Pfizer Investigational Site | Buffalo | New York | United States | |
| 77 | Pfizer Investigational Site | Flushing | New York | United States | |
| 78 | Pfizer Investigational Site | Johnson City | New York | United States | |
| 79 | Pfizer Investigational Site | New York | New York | United States | |
| 80 | Pfizer Investigational Site | Oneonta | New York | United States | |
| 81 | Pfizer Investigational Site | Poughkeepsie | New York | United States | |
| 82 | Pfizer Investigational Site | Rochester | New York | United States | |
| 83 | Pfizer Investigational Site | Troy | New York | United States | |
| 84 | Pfizer Investigational Site | Williamsville | New York | United States | |
| 85 | Pfizer Investigational Site | Eden | North Carolina | United States | |
| 86 | Pfizer Investigational Site | Greensboro | North Carolina | United States | |
| 87 | Pfizer Investigational Site | Greenville | North Carolina | United States | |
| 88 | Pfizer Investigational Site | Raleigh | North Carolina | United States | |
| 89 | Pfizer Investigational Site | Reidsville | North Carolina | United States | |
| 90 | Pfizer Investigational Site | Winston-Salem | North Carolina | United States | |
| 91 | Pfizer Investigational Site | Bellevue | Ohio | United States | |
| 92 | Pfizer Investigational Site | Cleveland | Ohio | United States | |
| 93 | Pfizer Investigational Site | Clyde | Ohio | United States | |
| 94 | Pfizer Investigational Site | Defiance | Ohio | United States | |
| 95 | Pfizer Investigational Site | Fostoria | Ohio | United States | |
| 96 | Pfizer Investigational Site | Middleburg Heights | Ohio | United States | |
| 97 | Pfizer Investigational Site | Orange Village | Ohio | United States | |
| 98 | Pfizer Investigational Site | Toledo | Ohio | United States | |
| 99 | Pfizer Investigational Site | Wauseon | Ohio | United States | |
| 100 | Pfizer Investigational Site | Westlake | Ohio | United States | |
| 101 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | |
| 102 | Pfizer Investigational Site | Tulsa | Oklahoma | United States | |
| 103 | Pfizer Investigational Site | Eugene | Oregon | United States | |
| 104 | Pfizer Investigational Site | Florence | Oregon | United States | |
| 105 | Pfizer Investigational Site | Hillsboro | Oregon | United States | |
| 106 | Pfizer Investigational Site | Doylestown | Pennsylvania | United States | |
| 107 | Pfizer Investigational Site | Harrisburg | Pennsylvania | United States | |
| 108 | Pfizer Investigational Site | Hershey | Pennsylvania | United States | |
| 109 | Pfizer Investigational Site | Lancaster | Pennsylvania | United States | |
| 110 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | |
| 111 | Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States | |
| 112 | Pfizer Investigational Site | Wormleysburg | Pennsylvania | United States | |
| 113 | Pfizer Investigational Site | Greenville | South Carolina | United States | |
| 114 | Pfizer Investigational Site | Chattanooga | Tennessee | United States | |
| 115 | Pfizer Investigational Site | Knoxville | Tennessee | United States | |
| 116 | Pfizer Investigational Site | Memphis | Tennessee | United States | |
| 117 | Pfizer Investigational Site | Oak Ridge | Tennessee | United States | |
| 118 | Pfizer Investigational Site | San Antonio | Texas | United States | |
| 119 | Pfizer Investigational Site | Annandale | Virginia | United States | |
| 120 | Pfizer Investigational Site | Charlottesville | Virginia | United States | |
| 121 | Pfizer Investigational Site | Falls Church | Virginia | United States | |
| 122 | Pfizer Investigational Site | Norfolk | Virginia | United States | |
| 123 | Pfizer Investigational Site | Richmond | Virginia | United States | |
| 124 | Pfizer Investigational Site | Bellevue | Washington | United States | |
| 125 | Pfizer Investigational Site | Seattle | Washington | United States | |
| 126 | Pfizer Investigational Site | Huntington | West Virginia | United States | |
| 127 | Pfizer Investigational Site | Milwaukee | Wisconsin | United States | |
| 128 | Pfizer Investigational Site | Aalst | Belgium | ||
| 129 | Pfizer Investigational Site | Bruxelles | Belgium | ||
| 130 | Pfizer Investigational Site | Genk | Belgium | ||
| 131 | Pfizer Investigational Site | Calgary | Alberta | Canada | |
| 132 | Pfizer Investigational Site | Victoria | British Columbia | Canada | |
| 133 | Pfizer Investigational Site | Halifax | Nova Scotia | Canada | |
| 134 | Pfizer Investigational Site | Ottawa | Ontario | Canada | |
| 135 | Pfizer Investigational Site | Torono | Ontario | Canada | |
| 136 | Pfizer Investigational Site | Montreal | Quebec | Canada | |
| 137 | Pfizer Investigational Site | Montréal | Quebec | Canada | |
| 138 | Pfizer Investigational Site | Nijmegen | Netherlands | ||
| 139 | Pfizer Investigational Site | Rotterdam | Netherlands | ||
| 140 | Pfizer Investigational Site | Katowice | Poland | ||
| 141 | Pfizer Investigational Site | Krakow | Poland | ||
| 142 | Pfizer Investigational Site | Warszawa | Poland | ||
| 143 | Pfizer Investigational Site | Oviedo | Asturias | Spain | |
| 144 | Pfizer Investigational Site | L´Hospitalet del Llobregat | Barcelona | Spain | |
| 145 | Pfizer Investigational Site | Vigo | Pontevedra | Spain | |
| 146 | Pfizer Investigational Site | Barcelona | Spain | ||
| 147 | Pfizer Investigational Site | Madrid | Spain |
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:
,
,
ClinicalTrials.gov Identifier:
NCT00134173
Other Study ID Numbers:
- A5091005
First Posted:
Aug 24, 2005
Last Update Posted:
Dec 10, 2007
Last Verified:
Apr 1, 2007
Additional relevant MeSH terms: