Coronary DiseasePhase 3ILLUSTRATENCT00134173
A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease
A Phase 3 study testing torcetrapib/atorvastatin and atorvastatin in people with Coronary Disease and Coronary Arteriosclerosis, run by Pfizer at 146 sites in 6 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Disease, Coronary Arteriosclerosis, Hyperlipidemia
- What is being tested?
- torcetrapib/atorvastatin and atorvastatin
- How many people
- 1,100 participants
- Where
- 146 sitesin 6 countries
- Study dates
- Oct 2003to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- angiographic evidence of coronary atherosclerosis
Who cannot join
- 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.
Trial locations and contacts
146 sites in 6 countries.
146 sites in 6 countries
United States127 sites
Pfizer Investigational Site
Albany, New York
Pfizer Investigational Site
Albuquerque, New Mexico
Pfizer Investigational Site
Ann Arbor, Michigan
Pfizer Investigational Site
Annandale, Virginia
Pfizer Investigational Site
Atlantis, Florida
Pfizer Investigational Site
Auburn, Maine
Pfizer Investigational Site
Baltimore, Maryland
Pfizer Investigational Site
Bay Shore, New York
Pfizer Investigational Site
Bellevue, Ohio
Pfizer Investigational Site
Bellevue, Washington
Pfizer Investigational Site
Birmingham, Alabama
Pfizer Investigational Site
Blue Island, Illinois
Pfizer Investigational Site
Bogalusa, Louisiana
Pfizer Investigational Site
Boulder, Colorado
Pfizer Investigational Site
Brandford, Connecticut
Pfizer Investigational Site
Buffalo, New York
Pfizer Investigational Site
Carlsbad, New Mexico
Pfizer Investigational Site
Charlottesville, Virginia
Pfizer Investigational Site
Chattanooga, Tennessee
Pfizer Investigational Site
Clearwater, Florida
Pfizer Investigational Site
Cleveland, Ohio
Pfizer Investigational Site
Clyde, Ohio
Pfizer Investigational Site
Columbia, Maryland
Pfizer Investigational Site
Covington, Louisiana
Pfizer Investigational Site
Davenport, Iowa
Pfizer Investigational Site
Defiance, Ohio
Pfizer Investigational Site
Denver, Colorado
Pfizer Investigational Site
Des Moines, Iowa
Pfizer Investigational Site
Doylestown, Pennsylvania
Pfizer Investigational Site
Duluth, Minnesota
Pfizer Investigational Site
Dunedin, Florida
Pfizer Investigational Site
Eden, North Carolina
Pfizer Investigational Site
Elkhart, Indiana
Pfizer Investigational Site
Eugene, Oregon
Pfizer Investigational Site
Falls Church, Virginia
Pfizer Investigational Site
Farmington, Connecticut
Pfizer Investigational Site
Flint, Michigan
Pfizer Investigational Site
Florence, Oregon
Pfizer Investigational Site
Flushing, New York
Pfizer Investigational Site
Fort Lauderdale, Florida
Pfizer Investigational Site
Fostoria, Ohio
Pfizer Investigational Site
Fresno, California
Pfizer Investigational Site
Goshen, Indiana
Pfizer Investigational Site
Greensboro, North Carolina
Pfizer Investigational Site
Greenville, North Carolina
Pfizer Investigational Site
Greenville, South Carolina
Pfizer Investigational Site
Guilford, Connecticut
Pfizer Investigational Site
Harrisburg, Pennsylvania
Pfizer Investigational Site
Hershey, Pennsylvania
Pfizer Investigational Site
Hillsboro, Oregon
Pfizer Investigational Site
Hobart, Indiana
Pfizer Investigational Site
Huntington, West Virginia
Pfizer Investigational Site
Jacksonville, Florida
Pfizer Investigational Site
Johnson City, New York
Pfizer Investigational Site
Kalamazoo, Michigan
Pfizer Investigational Site
Kansas City, Missouri
Pfizer Investigational Site
Knoxville, Tennessee
Pfizer Investigational Site
Lancaster, Pennsylvania
Pfizer Investigational Site
Lapeer, Michigan
Pfizer Investigational Site
Largo, Florida
Pfizer Investigational Site
Lewiston, Maine
Pfizer Investigational Site
Little Rock, Arkansas
Pfizer Investigational Site
Los Altos, California
Pfizer Investigational Site
Los Angeles, California
Pfizer Investigational Site
Louisville, Kentucky
Pfizer Investigational Site
Maplewood, Minnesota
Pfizer Investigational Site
Melbourne, Florida
Pfizer Investigational Site
Memphis, Tennessee
Pfizer Investigational Site
Merrillville, Indiana
Pfizer Investigational Site
Merrionette Park, Illinois
Pfizer Investigational Site
Miami, Florida
Pfizer Investigational Site
Middleburg Heights, Ohio
Pfizer Investigational Site
Milwaukee, Wisconsin
Pfizer Investigational Site
Minneapolis, Minnesota
Pfizer Investigational Site
Mobile, Alabama
Pfizer Investigational Site
Mountain View, California
Pfizer Investigational Site
New Haven, Connecticut
Pfizer Investigational Site
New Orleans, Louisiana
Pfizer Investigational Site
New York, New York
Pfizer Investigational Site
Norfolk, Virginia
Pfizer Investigational Site
Oak Ridge, Tennessee
Pfizer Investigational Site
Oklahoma City, Oklahoma
Pfizer Investigational Site
Omaha, Nebraska
Pfizer Investigational Site
Oneonta, New York
Pfizer Investigational Site
Orange, Ohio
Pfizer Investigational Site
Orlando, Florida
Pfizer Investigational Site
Pensacola, Florida
Pfizer Investigational Site
Petoskey, Michigan
Pfizer Investigational Site
Philadelphia, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania
Pfizer Investigational Site
Portland, Maine
Pfizer Investigational Site
Poughkeepsie, New York
Pfizer Investigational Site
Raleigh, North Carolina
Pfizer Investigational Site
Reidsville, North Carolina
Pfizer Investigational Site
Richmond, Virginia
Pfizer Investigational Site
Ridgewood, New Jersey
Pfizer Investigational Site
Rochester, New York
Pfizer Investigational Site
Rockford, Illinois
Pfizer Investigational Site
Royal Oak, Michigan
Pfizer Investigational Site
Sacramento, California
Pfizer Investigational Site
Safety Harbor, Florida
Pfizer Investigational Site
Saginaw, Michigan
Pfizer Investigational Site
Saint Cloud, Minnesota
Pfizer Investigational Site
Saint Paul, Minnesota
Pfizer Investigational Site
Salisbury, Maryland
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
San Diego, California
Pfizer Investigational Site
San Francisco, California
Pfizer Investigational Site
Santa Rosa, California
Pfizer Investigational Site
Sarasota, Florida
Pfizer Investigational Site
Scarborough, Maine
Pfizer Investigational Site
Seattle, Washington
Pfizer Investigational Site
Shawnee Mission, Kansas
Pfizer Investigational Site
Southaven, Mississippi
Pfizer Investigational Site
Stockton, California
Pfizer Investigational Site
Takoma Park, Maryland
Pfizer Investigational Site
Tampa, Florida
Pfizer Investigational Site
Toledo, Ohio
Pfizer Investigational Site
Troy, New York
Pfizer Investigational Site
Tulsa, Oklahoma
Pfizer Investigational Site
Wauseon, Ohio
Pfizer Investigational Site
West Des Moines, Iowa
Pfizer Investigational Site
Westlake, Ohio
Pfizer Investigational Site
Williamsville, New York
Pfizer Investigational Site
Winston-Salem, North Carolina
Pfizer Investigational Site
Wormleysburg, Pennsylvania
Pfizer Investigational Site
Ypsilanti, Michigan
Canada6 sites
Pfizer Investigational Site
Calgary, Alberta
Pfizer Investigational Site
Halifax, Nova Scotia
Pfizer Investigational Site
Montreal, Quebec
Pfizer Investigational Site
Ottawa, Ontario
Pfizer Investigational Site
Torono, Ontario
Pfizer Investigational Site
Victoria, British Columbia
Spain5 sites
Pfizer Investigational Site
Barcelona, Barcelona
Pfizer Investigational Site
L´Hospitalet Del Llobregat, Barcelona
Pfizer Investigational Site
Madrid, Madrid
Pfizer Investigational Site
Oviedo, Principality of Asturias
Pfizer Investigational Site
Vigo, Pontevedra
Belgium3 sites
Pfizer Investigational Site
Aalst
Pfizer Investigational Site
Brussels
Pfizer Investigational Site
Genk
Poland3 sites
Pfizer Investigational Site
Katowice
Pfizer Investigational Site
Krakow
Pfizer Investigational Site
Warsaw
Netherlands2 sites
Pfizer Investigational Site
Nijmegen
Pfizer Investigational Site
Rotterdam
About this study
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.
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
Read the detailed description
For additional information please call: 1-800-718-1021
- Conditions
- Coronary Disease, Coronary Arteriosclerosis, Hyperlipidemia
- Being tested
- torcetrapib/atorvastatin, atorvastatin
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
torcetrapib/atorvastatinDrug
atorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change coronary artery atheroma volume as measured by intravascular ultrasound.
Secondary outcomes (1)
Changes in levels of lipids and other biomarkers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startOct 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,100 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134173
- Sponsor's protocol ID
- A5091005
- Acronym
- ILLUSTRATE
- Status last verified
- Apr 2007
- First submitted
- 22 Aug 2005
- Last updated
- 10 Dec 2007
- Results posted
- No
Publications
Nicholls SJ, Tuzcu EM, Brennan DM, Tardif JC, Nissen SE. Cholesteryl ester transfer protein inhibition, high-density lipoprotein raising, and progression of coronary atherosclerosis: insights from ILLUSTRATE (Investigation of Lipid Level Management Using Coronary Ultrasound to Assess Reduction of Atherosclerosis by CETP Inhibition and HDL Elevation). Circulation. 2008 Dec 9;118(24):2506-14. doi: 10.1161/CIRCULATIONAHA.108.790733. Epub 2008 Nov 24.
PubMed 19029466Nissen SE, Tardif JC, Nicholls SJ, Revkin JH, Shear CL, Duggan WT, Ruzyllo W, Bachinsky WB, Lasala GP, Tuzcu EM; ILLUSTRATE Investigators. Effect of torcetrapib on the progression of coronary atherosclerosis. N Engl J Med. 2007 Mar 29;356(13):1304-16. doi: 10.1056/NEJMoa070635. Epub 2007 Mar 26.
PubMed 17387129
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00134173
- Acronym / sponsor ID
- ILLUSTRATE / A5091005
- Conditions
- Coronary Disease, Coronary Arteriosclerosis, Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Sep 2006 (actual)
- First posted
- 24 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
For additional information please call: 1-800-718-1021
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- angiographic evidence of coronary atherosclerosis
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| torcetrapib/atorvastatin | Drug | – |
| atorvastatin | Drug | – |
Primary outcome
Change coronary artery atheroma volume as measured by intravascular ultrasound.
1 secondary outcome
Changes in levels of lipids and other biomarkers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2007.
- Derived from this study: PubMed 19029466Nicholls SJ, Tuzcu EM, Brennan DM, Tardif JC, Nissen SE. Cholesteryl ester transfer protein inhibition, high-density lipoprotein raising, and progression of coronary atherosclerosis: insights from ILLUSTRATE (Investigation of Lipid Level Management Using Coronary Ultrasound to Assess Reduction of Atherosclerosis by CETP Inhibition and HDL Elevation). Circulation. 2008 Dec 9;118(24):2506-14. doi: 10.1161/CIRCULATIONAHA.108.790733. Epub 2008 Nov 24.
- Derived from this study: PubMed 17387129Nissen SE, Tardif JC, Nicholls SJ, Revkin JH, Shear CL, Duggan WT, Ruzyllo W, Bachinsky WB, Lasala GP, Tuzcu EM; ILLUSTRATE Investigators. Effect of torcetrapib on the progression of coronary atherosclerosis. N Engl J Med. 2007 Mar 29;356(13):1304-16. doi: 10.1056/NEJMoa070635. Epub 2007 Mar 26.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
146 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing torcetrapib/atorvastatin and atorvastatin in people with Coronary Disease and Coronary Arteriosclerosis, run by Pfizer at 146 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 146 sites in United States, Canada, Spain, Belgium, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change coronary artery atheroma volume as measured by intravascular ultrasound.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00134173, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2007.