ILLUSTRATE Trial

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Official Title

Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Angiographically Documented Coronary Heart Disease

Objective

• The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
• To look at ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease

Sponsor

Pfizer

Timeline

Timeline
Start Date	October 2003
End Date	Not provided
Status	Completed

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00134173.

Study Description

Study Description
Study Type	Interventional
Study Phase	Phase 3
Study Design
Allocation	Randomized
Endpoint	Safety/Efficacy Study
Interventional Model	Parallel Assignment
Masking	Double-Blind
Study Details
Primary Purpose	Treatment
Condition	Coronary Disease Coronary Arteriosclerosis Hyperlipidemia
Intervention	Drug: torcetrapib/atorvastatin Drug: atorvastatin
Study Arms	Not provided
Population Size	1100

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00134173.

Eligibility Criteria

Inclusion Criteria

• Angiographic evidence of coronary atherosclerosis

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 evaluation of response, or render unlikely :that the subject would complete the study.

Outcomes

Primary Outcomes

Change coronary artery atheroma volume as measured by intravascular ultrasound.

Secondary Outcomes

Changes in levels of lipids and other biomarkers.