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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00134264
Ethics application status
Date submitted
22/08/2005
Date registered
22/08/2005
Date last updated
30/01/2012

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
Metabolic and Endocrine 0 0 0 0
Diabetes
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
Treatment: Drugs - torcetrapib/atorvastatin
Treatment: Drugs - atorvastatin

Treatment: Drugs: torcetrapib/atorvastatin


Treatment: Drugs: atorvastatin


Intervention code [1] 0 0
Treatment: Drugs
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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United States of America
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Colorado
Country [5] 0 0
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Connecticut
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District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
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Indiana
Country [11] 0 0
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Iowa
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United States of America
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Kansas
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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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Oklahoma
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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/show/NCT00134264
Trial related presentations / publications
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

No data has been provided for results reporting
Summary results
Not applicable