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[edit | edit source]
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[edit | edit source]
- 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[edit | edit source]
Pfizer
Timeline[edit | edit source]
| 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[edit | edit source]
| 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[edit | edit source]
Inclusion Criteria[edit | edit source]
- Angiographic evidence of coronary atherosclerosis
Exclusion Criteria[edit | edit source]
- 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[edit | edit source]
Primary Outcomes[edit | edit source]
Change coronary artery atheroma volume as measured by intravascular ultrasound.
Secondary Outcomes[edit | edit source]
Changes in levels of lipids and other biomarkers.
Publications[edit | edit source]
Results[edit | edit source]
Conclusion[edit | edit source]
References[edit | edit source]
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