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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
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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
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Secondary ID [1]
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A5091043
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Universal Trial Number (UTN)
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Trial acronym
ILLUMINATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Disease
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Diabetes Mellitus
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Condition category
Condition code
Cardiovascular
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0
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0
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Coronary heart disease
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Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The time to first occurrence of a major cardiovascular disease event
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Various composites of major cardiovascular disease events and other lipid parameters
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
* Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events
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Minimum age
45
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2007
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Sample size
Target
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Accrual to date
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Final
15067
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Pfizer Investigational Site - Concord
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Pfizer Investigational Site - East Gosford
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Pfizer Investigational Site - St. Leonards
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Pfizer Investigational Site - Launceston, Tas
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Pfizer Investigational Site - Southport
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Recruitment postcode(s) [1]
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- Concord
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- East Gosford
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- St. Leonards
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- Wollongong
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- Adelaide
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- Bedford Park
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- Woodville
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- Clayton
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- Fitzroy
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- Launceston, Tas
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- Melbourne
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- Nedlands
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- Perth
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- Southport
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Leicester
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Country [122]
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United Kingdom
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State/province [122]
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Liverpool
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United Kingdom
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Newcastle-upon-Tyne
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United Kingdom
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Romford
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Shrewsbury
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Warwick
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Ethics approval
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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
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Trial website
https://clinicaltrials.gov/study/NCT00134264
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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.
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Public notes
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Contacts
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00134264
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