ILLUSTRATE Trial

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

Click here to download slides for ILLUSTRATE Trial.

## Official Title

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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

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* 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

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Pfizer

## Timeline

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Timeline

Start Date | October 2003
End Date | September 2006
Status | Completed

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

## Study Description

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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

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### Inclusion Criteria

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* Angiographic evidence of coronary atherosclerosis

### Exclusion Criteria

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* 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

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### Primary Outcomes

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Change coronary artery atheroma volume as measured by intravascular ultrasound.

### Secondary Outcomes

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Changes in levels of lipids and other biomarkers.

## Publications

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### Results

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### Conclusion

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## References

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* v
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Lipopedia

Basic Science|

Cholesterol • Triglyceride

Lipoprotein metabolism and transport

Lipoprotein: Chylomicron • Chylomicron remnant • HDL • IDL • LDL • Lipoprotein(a) • VLDL • Lipoprotein-X

Apolipoprotein: APOA (1, 2, 4,  5) • APOB ( Apolipoprotein B-48, Apolipoprotein B-100) • APOC (1, 2, 3, 4) • APOD • APOE • APOH • APOJ • APOL • APOM • Apo(a)

Lipoprotein receptor: LDL receptor • Soluble low density lipoprotein receptor-related protein (sLRP) • Apolipoprotein E Receptor 2 • Scavenger receptor • Scavenger receptor A • Scavenger receptor B • VLDL receptor

Lipoprotein enzymes: Lipoprotein lipase • Lipoprotein-associated phospholipase A2 (Lp-PLA2) • Cholesterylester transfer protein ( Acetyl-CoA C-acyltransferase, Lecithin-cholesterol acyltransferase) • Microsomal triglyceride transfer protein • ABCA1

Genes: Low density lipoprotein receptor gene family • Microsomal triglyceride transfer protein • ABCA1

Lipoprotein Disorders|

Lipoprotein disorders

Primary lipoprotein disorders: Familial hyperchylomicronemia (Type I) • Familial hypercholesterolemia (Type IIA) • Familial combined hyperlipidemia (Type IIB) • Dysbetalipoproteinemia (Type III) • Primary hypertriglyceridemia (Type IV) • Mixed hyperlipoproteinemia (Type V)

Secondary lipoprotein disorders

Abnormal Laboratory Lipid Profile|

Low chylomicron • Low chylomicron remnant • Low HDL • Low IDL • Low LDL • Low lipoprotein(a) • Low VLDL

High chylomicron • High chylomicron remnant • High HDL • High IDL • High LDL • High Lipoprotein(a) • High VLDL
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