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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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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Coronary heart disease
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Cardiovascular
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0
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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
Treatment: Drugs - torcetrapib/atorvastatin
Treatment: Drugs - atorvastatin
Treatment: Drugs: torcetrapib/atorvastatin
Treatment: Drugs: atorvastatin
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Intervention code [1]
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0
Treatment: Drugs
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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
Terminated
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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 - Southport
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- Concord
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- East Gosford
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- St. Leonards
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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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- Nedlands
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- Perth
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- Southport
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Harrow
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Country [121]
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United Kingdom
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State/province [121]
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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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Country [123]
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United Kingdom
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State/province [123]
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Newcastle-upon-Tyne
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Country [124]
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United Kingdom
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State/province [124]
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Romford
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Country [125]
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United Kingdom
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State/province [125]
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Shrewsbury
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Country [126]
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United Kingdom
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State/province [126]
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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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Address
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Ethics approval
Ethics application status
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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/ct2/show/NCT00134264
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Fax
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Email
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Contact person for public queries
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00134264
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