Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Coronary Artery Disease

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn if CS-505 is safe and effective for slowing down or possibly reversing the buildup of tissue, cells and fatty deposits (plaque) in the blood vessels of the heart (coronary artery atherosclerosis).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.

Criteria

Inclusion Criteria:

Standard:

1. Male or female subjects, age 18 years or greater; and

2. Diagnosed or suspected coronary artery disease with a clinical indication for coronary angiography.

Angiographic:

1. Evidence of coronary heart disease

2. Identification of a target native coronary artery for the plaque volume measurement.

Exclusion Criteria:

Standard:

1. Breast feeding or lactating women, or women who have had a pregnancy (regardless of outcome) within the past 12 months;

2. Previous heart or other organ transplantation;

3. 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.

4. 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.

5. Stroke (CVA) within previous 3 months;

6. Evidence of severe symptomatic heart failure (NYHA Class III or IV) or known ejection fraction less than 30%;

7. Uncontrolled diabetes mellitus;

8. Uncontrolled hypertension; and

9. Nephrotic syndrome, significant nephropathy, or other significant renal disease.

Angiographic:

1. Presence of any lesion with greater than 50% reduction in lumen diameter; or

2. Any lesion with a greater than 50% occlusion in the left main coronary artery;

3. 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);

4. A target vessel that is itself a bypass graft.