AzTrials
AzTrials

Coronary DiseasePhase 3ILLUMINATENCT00134264

A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease

A Phase 3 study testing torcetrapib/atorvastatin and atorvastatin in people with Coronary Disease and Diabetes Mellitus, run by Pfizer at 221 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Coronary Disease, Diabetes Mellitus
What is being tested?
torcetrapib/atorvastatin and atorvastatin
How many people
15,067 participants
Where
221 sitesin 7 countries
Study dates
Jul 2004to Jun 2007
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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events

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 evaluationof response, or render unlikely that the subject would complete the study

Trial locations and contacts

221 sites in 7 countries.

221 sites in 7 countries

United States95 sites

  • Pfizer Investigational Site

    Abington, Massachusetts

  • Pfizer Investigational Site

    Alabaster, Alabama

  • Pfizer Investigational Site

    Atlanta, Georgia

  • Pfizer Investigational Site

    Aurora, Illinois

  • Pfizer Investigational Site

    Baltimore, Maryland

  • Pfizer Investigational Site

    Baton Rouge, Louisiana

  • Pfizer Investigational Site

    Beaumont, Texas

  • Pfizer Investigational Site

    Beaver, Pennsylvania

  • Pfizer Investigational Site

    Bel Air, Maryland

  • Pfizer Investigational Site

    Billings, Montana

  • Pfizer Investigational Site

    Birmingham, Alabama

  • Pfizer Investigational Site

    Blue Island, Illinois

  • Pfizer Investigational Site

    Burien, Washington

  • Pfizer Investigational Site

    Burlington, Vermont

  • Pfizer Investigational Site

    Butte, Montana

  • Pfizer Investigational Site

    Chicago, Illinois

  • Pfizer Investigational Site

    Cincinnati, Ohio

  • Pfizer Investigational Site

    Clearwater, Florida

  • Pfizer Investigational Site

    Cleveland, Ohio

  • Pfizer Investigational Site

    Columbia, Maryland

  • Pfizer Investigational Site

    Columbus, Ohio

  • Pfizer Investigational Site

    Concord, New Hampshire

  • Pfizer Investigational Site

    Coral Gables, Florida

  • Pfizer Investigational Site

    Covington, Louisiana

  • Pfizer Investigational Site

    Dallas, Texas

  • Pfizer Investigational Site

    Davenport, Iowa

  • Pfizer Investigational Site

    Denver, Colorado

  • Pfizer Investigational Site

    Des Moines, Iowa

  • Pfizer Investigational Site

    Durham, North Carolina

  • Pfizer Investigational Site

    Elmer, New Jersey

  • Pfizer Investigational Site

    Evansville, Indiana

  • Pfizer Investigational Site

    Fort Meyers, Florida

  • Pfizer Investigational Site

    Fort Wayne, Indiana

  • Pfizer Investigational Site

    Fresno, California

  • Pfizer Investigational Site

    Garden City, New York

  • Pfizer Investigational Site

    Gilbert, Arizona

  • Pfizer Investigational Site

    Grand Rapids, Michigan

  • Pfizer Investigational Site

    Guilford, Connecticut

  • Pfizer Investigational Site

    Haddon Heights, New Jersey

  • Pfizer Investigational Site

    Hartford, Connecticut

  • Pfizer Investigational Site

    Haverhill, Massachusetts

  • Pfizer Investigational Site

    Houston, Texas

  • Pfizer Investigational Site

    Iowa City, Iowa

  • Pfizer Investigational Site

    Jacksonville, Florida

  • Pfizer Investigational Site

    Jacksonville Beach, Florida

  • Pfizer Investigational Site

    Kingsport, Tennessee

  • Pfizer Investigational Site

    Lakeland, Florida

  • Pfizer Investigational Site

    Las Vegas, Nevada

  • Pfizer Investigational Site

    Lebanon, New Hampshire

  • Pfizer Investigational Site

    Longmont, Colorado

  • Pfizer Investigational Site

    Los Angeles, California

  • Pfizer Investigational Site

    Louisville, Kentucky

  • Pfizer Investigational Site

    Manchester, New Hampshire

  • Pfizer Investigational Site

    Mansfield, Ohio

  • Pfizer Investigational Site

    Marrero, Louisiana

  • Pfizer Investigational Site

    Minneapolis, Minnesota

  • Pfizer Investigational Site

    Modesto, California

  • Pfizer Investigational Site

    Nashville, Tennessee

  • Pfizer Investigational Site

    Natick, Massachusetts

  • Pfizer Investigational Site

    New Brunswick, New Jersey

  • Pfizer Investigational Site

    New Hyde Park, New York

  • Pfizer Investigational Site

    Norfolk, Virginia

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma

  • Pfizer Investigational Site

    Omaha, Nebraska

  • Pfizer Investigational Site

    Orlando, Florida

  • Pfizer Investigational Site

    Papillon, Nebraska

  • Pfizer Investigational Site

    Pensacola, Florida

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania

  • Pfizer Investigational Site

    Phoenix, Arizona

  • Pfizer Investigational Site

    Plano, Texas

  • Pfizer Investigational Site

    Port Charlotte, Florida

  • Pfizer Investigational Site

    Portland, Oregon

  • Pfizer Investigational Site

    Richmond, Virginia

  • Pfizer Investigational Site

    Rochester, New York

  • Pfizer Investigational Site

    Saint Paul, Minnesota

  • Pfizer Investigational Site

    Salt Lake City, Utah

  • Pfizer Investigational Site

    San Antonio, Texas

  • Pfizer Investigational Site

    San Diego, California

  • Pfizer Investigational Site

    Sandusky, Ohio

  • Pfizer Investigational Site

    Santa Rosa, California

  • Pfizer Investigational Site

    Sarasota, Florida

  • Pfizer Investigational Site

    Scarborough, Maine

  • Pfizer Investigational Site

    St Louis, Missouri

  • Pfizer Investigational Site

    Tacoma, Washington

  • Pfizer Investigational Site

    Toledo, Ohio

  • Pfizer Investigational Site

    Towson, Maryland

  • Pfizer Investigational Site

    Tucson, Arizona

  • Pfizer Investigational Site

    Tustin, California

  • Pfizer Investigational Site

    Walnut Creek, California

  • Pfizer Investigational Site

    Washington D.C., District of Columbia

  • Pfizer Investigational Site

    West Palm Beach, Florida

  • Pfizer Investigational Site

    Westminster, Maryland

  • Pfizer Investigational Site

    Wichita, Kansas

  • Pfizer Investigational Site

    Winston-Salem, North Carolina

  • Pfizer Investigational Site

    Witchita, Kansas

Other trials in United States

Australia25 sites

  • Pfizer Investigational Site

    Adelaide, South Australia

  • Pfizer Investigational Site

    Bedford Park, South Australia

  • Pfizer Investigational Site

    Camperdown

  • Pfizer Investigational Site

    Chermside, Queensland

  • Pfizer Investigational Site

    Clayton, Victoria

  • Pfizer Investigational Site

    Concord, New South Wales

  • Pfizer Investigational Site

    Darlinghurst

  • Pfizer Investigational Site

    East Gosford, New South Wales

  • Pfizer Investigational Site

    Fitzroy, Victoria

  • Pfizer Investigational Site

    Footscray, Victoria

  • Pfizer Investigational Site

    Fremantle, Western Australia

  • Pfizer Investigational Site

    Geelong

  • Pfizer Investigational Site

    Heidelberg, Victoria

  • Pfizer Investigational Site

    Herston, Queensland

  • Pfizer Investigational Site

    Joondalup, Western Australia

  • Pfizer Investigational Site

    Launceston, Tas

  • Pfizer Investigational Site

    Melbourne

  • Pfizer Investigational Site

    Nedlands

  • Pfizer Investigational Site

    Perth

  • Pfizer Investigational Site

    Prahran, Victoria

  • Pfizer Investigational Site

    Southport

  • Pfizer Investigational Site

    St Leonards, New South Wales

  • Pfizer Investigational Site

    Wollongong, New South Wales

  • Pfizer Investigational Site

    Woodville, South Australia

  • Pfizer Investigational Site

    Woolloongabba, Queensland

Other trials in Australia

United Kingdom24 sites

  • Pfizer Investigational Site

    Aberdeen

  • Pfizer Investigational Site

    Bath

  • Pfizer Investigational Site

    Birmingham

  • Pfizer Investigational Site

    Bournemouth

  • Pfizer Investigational Site

    Brighton, East Sussex

  • Pfizer Investigational Site

    Bristol

  • Pfizer Investigational Site

    Cardiff

  • Pfizer Investigational Site

    Chichester

  • Pfizer Investigational Site

    Coventry

  • Pfizer Investigational Site

    Dundee

  • Pfizer Investigational Site

    Edinburgh

  • Pfizer Investigational Site

    Exeter

  • Pfizer Investigational Site

    Glasgow, Scotland

  • Pfizer Investigational Site

    Glasgow

  • Pfizer Investigational Site

    Harrow

  • Pfizer Investigational Site

    Leicester

  • Pfizer Investigational Site

    Liverpool

  • Pfizer Investigational Site

    London

  • Pfizer Investigational Site

    Newcastle upon Tyne

  • Pfizer Investigational Site

    Romford

  • Pfizer Investigational Site

    Shrewsbury

  • Pfizer Investigational Site

    Warwick

  • Pfizer Investigational Site

    Woolwich, London

  • Pfizer Investigational Site

    Wrexham, Clwyd

Other trials in United Kingdom

Netherlands23 sites

  • Pfizer Investigational Site

    's-Hertogenbosch

  • Pfizer Investigational Site

    Amsterdam

  • Pfizer Investigational Site

    AN Rotterdam

  • Pfizer Investigational Site

    Apeldoorn

  • Pfizer Investigational Site

    Arnhem

  • Pfizer Investigational Site

    Breda

  • Pfizer Investigational Site

    Cappelle Aan Den IJssel

  • Pfizer Investigational Site

    Delft

  • Pfizer Investigational Site

    Eindhoven

  • Pfizer Investigational Site

    Goes

  • Pfizer Investigational Site

    Gouda

  • Pfizer Investigational Site

    Groningen

  • Pfizer Investigational Site

    Heerlen

  • Pfizer Investigational Site

    Hoorn

  • Pfizer Investigational Site

    Leiden

  • Pfizer Investigational Site

    Maastricht

  • Pfizer Investigational Site

    Nijmegen

  • Pfizer Investigational Site

    Rotterdam

  • Pfizer Investigational Site

    Sittard

  • Pfizer Investigational Site

    Utrecht

  • Pfizer Investigational Site

    Velp

  • Pfizer Investigational Site

    Venlo

  • Pfizer Investigational Site

    Zoetermeer

Other trials in Netherlands

Sweden20 sites

  • Pfizer Investigational Site

    Borås

  • Pfizer Investigational Site

    Eskilstuna

  • Pfizer Investigational Site

    Gothenburg

  • Pfizer Investigational Site

    Hässleholm

  • Pfizer Investigational Site

    Helsingborg

  • Pfizer Investigational Site

    Karlshamn

  • Pfizer Investigational Site

    Köping

  • Pfizer Investigational Site

    Linköping

  • Pfizer Investigational Site

    Luleå

  • Pfizer Investigational Site

    Lund

  • Pfizer Investigational Site

    Malmö

  • Pfizer Investigational Site

    Mölndal

  • Pfizer Investigational Site

    Norrköping

  • Pfizer Investigational Site

    Östersund

  • Pfizer Investigational Site

    Skellefteå

  • Pfizer Investigational Site

    Stockholm

  • Pfizer Investigational Site

    Uddevalla

  • Pfizer Investigational Site

    Uppsala

  • Pfizer Investigational Site

    Västervik

  • Pfizer Investigational Site

    Vaxjo

Other trials in Sweden

Spain18 sites

  • Pfizer Investigational Site

    Almería, Almeria

  • Pfizer Investigational Site

    Barcelona, Barcelona

  • Pfizer Investigational Site

    Ciudad Real, Ciudad Real

  • Pfizer Investigational Site

    Donostia / San Sebastian, Guipuzcoa

  • Pfizer Investigational Site

    Ferrol, La Coruna

  • Pfizer Investigational Site

    Granada, Granada

  • Pfizer Investigational Site

    Jerez de la Frontera, Cadiz

  • Pfizer Investigational Site

    Madrid, Madrid

  • Pfizer Investigational Site

    Madrid

  • Pfizer Investigational Site

    Málaga, Malaga

  • Pfizer Investigational Site

    Salamanca

  • Pfizer Investigational Site

    Sant Coloma de Gramenet, Barcelona

  • Pfizer Investigational Site

    Santander, Cantabria

  • Pfizer Investigational Site

    Santiago de Compostela, La Coruña

  • Pfizer Investigational Site

    Seville, Sevilla

  • Pfizer Investigational Site

    Terrassa, Barcelona

  • Pfizer Investigational Site

    Valencia, Valencia

  • Pfizer Investigational Site

    Zaragoza, Zaragoza

Other trials in Spain

Canada16 sites

  • Pfizer Investigational Site

    Calgary, Alberta

  • Pfizer Investigational Site

    Cornwall, Ontario

  • Pfizer Investigational Site

    Halifax, Nova Scotia

  • Pfizer Investigational Site

    Laval, Quebec

  • Pfizer Investigational Site

    Montreal, Quebec

  • Pfizer Investigational Site

    Newmarket, Ontario

  • Pfizer Investigational Site

    Oshawa, Ontario

  • Pfizer Investigational Site

    Sainte-Foy, Quebec

  • Pfizer Investigational Site

    Sarnia, Ontario

  • Pfizer Investigational Site

    Scarborough Village, Ontario

  • Pfizer Investigational Site

    Sherbrooke, Quebec

  • Pfizer Investigational Site

    St. John's

  • Pfizer Investigational Site

    Ste-foy, Quebec

  • Pfizer Investigational Site

    Toronto, Ontario

  • Pfizer Investigational Site

    Vancouver, British Columbia

  • Pfizer Investigational Site

    Winnipeg, Manitoba

Other trials in Canada

About this study

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

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

Being tested
torcetrapib/atorvastatin, atorvastatin
Medical subject headings
Coronary Disease, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The time to first occurrence of a major cardiovascular disease event

Secondary outcomes (1)

  1. Various composites of major cardiovascular disease events and other lipid parameters

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2005 (estimated)
  2. Study startJul 2004
  3. Primary completionJun 2007
  4. Study completionJun 2007

Resources

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
15,067 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00134264
Sponsor's protocol ID
A5091043
Acronym
ILLUMINATE
Status last verified
Jan 2012
First submitted
22 Aug 2005
Last updated
3 Feb 2012
Results posted
No

Publications

  • 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.

    PubMed 29103916

  • 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.

    PubMed 28974520

  • 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.

    PubMed 28431663

  • 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.

    PubMed 21804130

  • 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.

    PubMed 20645885

  • 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.

    PubMed 20228610

  • 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.

    PubMed 19029469

  • 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.

    PubMed 17984165

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 Diabetes Mellitus, run by Pfizer at 221 sites in 7 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: stopped early, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 221 sites in United States, Australia, United Kingdom, Netherlands, Sweden and 2 more countries. 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 was stopped early. Results are not available in the source record.

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?

The time to first occurrence of a major cardiovascular disease event. 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 NCT00134264, which also lists 8 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 3 Feb 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in