Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Carotid Artery Disease. This Study is Also Known as CAPTIVATE.

A Randomized, Double-blind, Stratified, 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 Heterozygous Familial Hypercholesterolemia and Carotid Atherosclerosis Using Carotid Ultrasound (CUS)

The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.

Inclusion Criteria:

• Confirmed diagnosis of heterozygous familial hypercholesterolemia
• Ambulatory male (40 to 75 years, inclusive) or female (45 to 75 years, inclusive) subjects
• Calculated LDL-C level greater than or equal to 100 mg/dL (or 2.5 mmol/L) and triglycerides less than 500 mg/dL (5.65 mmol/L) while on usual and stable lipid-lowering therapy

Exclusion Criteria:

• Breast feeding or lactating women
• Previous organ transplantation
• High-grade stenosis (>75%) or the occlusion of any segment of either carotid artery
• History of carotid endarterectomy, or insertion of carotid artery stent or are scheduled to have either of these procedures