Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Coronary Artery Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00185042 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : September 11, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease | Drug: Pactimibe, CS-505 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 534 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of the ACAT Inhibitor CS-505 for Reducing the Progression of Atherosclerosis in Subjects With Coronary Artery Disease Using Intravascular Ultrasound (IVUS) |
Study Start Date : | November 2002 |
Study Completion Date : | July 2005 |

- To compare the effect of CS-505 versus placebo when added to usual medical care on the change from baseline in percent atheroma volume, as measured by intravascular ultrasound (IVUS) of the identified target coronary artery segment
- To compare the effect of CS-505 versus placebo when added to usual medical care on:
- - change from baseline in total atheroma volume in
- various arteries;
- - changes in minimum luminal diameter and percent
- diameter stenosis;
- - incidence and time to first occurrence of
- cardiovascular events.
- To compare the safety of CS-505 versus placebo

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Standard:
- Male or female subjects, age 18 years or greater; and
- Diagnosed or suspected coronary artery disease with a clinical indication for coronary angiography.
Angiographic:
- Evidence of coronary heart disease
- Identification of a target native coronary artery for the plaque volume measurement.
Exclusion Criteria:
Standard:
- Breast feeding or lactating women, or women who have had a pregnancy (regardless of outcome) within the past 12 months;
- Previous heart or other organ transplantation;
-
Treatment with any of the following agents within 4 weeks prior to randomization:
- Immunosuppressive agents (cyclosporine, azathioprine);
- Rifampin; and
- Phenytoin, phenobarbital, valproic acid, or other anticonvulsants.
-
Any of the following manifestations of cardiac disease:
- Myocardial infarction or unstable angina within 24 hours prior to randomization or clinically unstable;
- Clinically significant heart disease; and
- Coronary artery bypass surgery within previous 3 months.
- Stroke (CVA) within previous 3 months;
- Evidence of severe symptomatic heart failure (NYHA Class III or IV) or known ejection fraction less than 30%;
- Uncontrolled diabetes mellitus;
- Uncontrolled hypertension; and
- Nephrotic syndrome, significant nephropathy, or other significant renal disease.
Angiographic:
- Presence of any lesion with greater than 50% reduction in lumen diameter; or
- Any lesion with a greater than 50% occlusion in the left main coronary artery;
- A target vessel, including any of its branches, that has undergone or will be undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI);
- A target vessel that is itself a bypass graft.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185042
United States, Alabama | |
Birmingham, Alabama, United States | |
Huntsville, Alabama, United States | |
Mobile, Alabama, United States | |
United States, Arizona | |
Phoenix, Arizona, United States | |
United States, California | |
Los Angeles, California, United States | |
San Diego, California, United States | |
United States, Colorado | |
Fort Collins, Colorado, United States | |
United States, Connecticut | |
Bridgeport, Connecticut, United States | |
United States, Delaware | |
Newark, Delaware, United States | |
United States, Florida | |
Clearwater, Florida, United States | |
Gainsville, Florida, United States | |
Hudson, Florida, United States | |
Jacksonville, Florida, United States | |
Melbourne, Florida, United States | |
Miami, Florida, United States | |
Pensacola, Florida, United States | |
Port Charlotte, Florida, United States | |
Sarasota, Florida, United States | |
Tallahassee, Florida, United States | |
Tampa, Florida, United States | |
United States, Georgia | |
Atlanta, Georgia, United States | |
United States, Illinois | |
Springfield, Illinois, United States | |
United States, Kentucky | |
Louisville, Kentucky, United States | |
United States, Maryland | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Springfield, Massachusetts, United States | |
United States, Michigan | |
Grand Rapids, Michigan, United States | |
Kalamazoo, Michigan, United States | |
United States, Minnesota | |
Duluth, Minnesota, United States | |
Minneapolis, Minnesota, United States | |
United States, Missouri | |
Kansas City, Missouri, United States | |
United States, Nebraska | |
Lincoln, Nebraska, United States | |
United States, New York | |
New York, New York, United States | |
Rochester, New York, United States | |
Troy, New York, United States | |
United States, North Carolina | |
Charlotte, North Carolina, United States | |
Greenville, North Carolina, United States | |
High Point, North Carolina, United States | |
Winston-Salem, North Carolina, United States | |
United States, Ohio | |
Akron, Ohio, United States | |
Cleveland, Ohio, United States | |
Elyria, Ohio, United States | |
Mansfield, Ohio, United States | |
United States, Oklahoma | |
Oklahoma City, Oklahoma, United States | |
United States, Pennsylvania | |
Doylestown, Pennsylvania, United States | |
United States, Tennessee | |
Memphis, Tennessee, United States | |
United States, Texas | |
San Antonio, Texas, United States |
ClinicalTrials.gov Identifier: | NCT00185042 |
Other Study ID Numbers: |
505-202 |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | September 11, 2007 |
Last Verified: | September 2007 |
Atherosclerosis, intravascular ultrasound |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |