ILLUSTRATE Trial
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ILLUSTRATE Trial On the Web |
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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
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 | September 2006 |
| 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.