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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00134264




Registration number
NCT00134264
Ethics application status
Date submitted
22/08/2005
Date registered
24/08/2005
Date last updated
3/02/2012

Titles & IDs
Public title
A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease
Scientific 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
Secondary ID [1] 0 0
A5091043
Universal Trial Number (UTN)
Trial acronym
ILLUMINATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Disease 0 0
Diabetes Mellitus 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The time to first occurrence of a major cardiovascular disease event
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Various composites of major cardiovascular disease events and other lipid parameters
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
15067
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Concord
Recruitment hospital [2] 0 0
Pfizer Investigational Site - East Gosford
Recruitment hospital [3] 0 0
Pfizer Investigational Site - St. Leonards
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Wollongong
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Chermside
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Woolloongabba
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [9] 0 0
Pfizer Investigational Site - Bedford Park
Recruitment hospital [10] 0 0
Pfizer Investigational Site - Woodville
Recruitment hospital [11] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [12] 0 0
Pfizer Investigational Site - Fitzroy
Recruitment hospital [13] 0 0
Pfizer Investigational Site - Footscray
Recruitment hospital [14] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment hospital [15] 0 0
Pfizer Investigational Site - Prahran
Recruitment hospital [16] 0 0
Pfizer Investigational Site - Fremantle
Recruitment hospital [17] 0 0
Pfizer Investigational Site - Joondalup
Recruitment hospital [18] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [19] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [20] 0 0
Pfizer Investigational Site - Geelong
Recruitment hospital [21] 0 0
Pfizer Investigational Site - Launceston, Tas
Recruitment hospital [22] 0 0
Pfizer Investigational Site - Melbourne
Recruitment hospital [23] 0 0
Pfizer Investigational Site - Nedlands
Recruitment hospital [24] 0 0
Pfizer Investigational Site - Perth
Recruitment hospital [25] 0 0
Pfizer Investigational Site - Southport
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- East Gosford
Recruitment postcode(s) [3] 0 0
- St. Leonards
Recruitment postcode(s) [4] 0 0
- Wollongong
Recruitment postcode(s) [5] 0 0
- Chermside
Recruitment postcode(s) [6] 0 0
- Herston
Recruitment postcode(s) [7] 0 0
- Woolloongabba
Recruitment postcode(s) [8] 0 0
- Adelaide
Recruitment postcode(s) [9] 0 0
- Bedford Park
Recruitment postcode(s) [10] 0 0
- Woodville
Recruitment postcode(s) [11] 0 0
- Clayton
Recruitment postcode(s) [12] 0 0
- Fitzroy
Recruitment postcode(s) [13] 0 0
- Footscray
Recruitment postcode(s) [14] 0 0
- Heidelberg
Recruitment postcode(s) [15] 0 0
- Prahran
Recruitment postcode(s) [16] 0 0
- Fremantle
Recruitment postcode(s) [17] 0 0
- Joondalup
Recruitment postcode(s) [18] 0 0
- Camperdown
Recruitment postcode(s) [19] 0 0
- Darlinghurst
Recruitment postcode(s) [20] 0 0
- Geelong
Recruitment postcode(s) [21] 0 0
- Launceston, Tas
Recruitment postcode(s) [22] 0 0
- Melbourne
Recruitment postcode(s) [23] 0 0
- Nedlands
Recruitment postcode(s) [24] 0 0
- Perth
Recruitment postcode(s) [25] 0 0
- Southport
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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District of Columbia
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Iowa
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Utah
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Vermont
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Sweden
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United Kingdom
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London
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Scotland
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Bath
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Birmingham
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Bristol
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Cardiff
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Chichester
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Coventry
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Dundee
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Edinburgh
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Exeter
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Glasgow
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Harrow
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Leicester
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Liverpool
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Newcastle-upon-Tyne
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Romford
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Shrewsbury
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Warwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT00134264
Trial related presentations / 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.
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.
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.
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.
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.
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.
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. Erratum In: Circulation. 2009 Feb 10;119(5):e197.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00134264