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.
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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)
Study Start Date
Primary Completion Date
Study Completion Date
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To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis.
Secondary Outcome Measures
To assess the effects of pactimibe versus placebo, when added to usual medical care:
- on the incidence and the time to first occurrence of
- on inflammatory and oxidative markers, such as serum
high-sensitivity C-reactive protein (hsCRP), plasma
interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and
To compare the safety of pactimibe versus placebo, when added to usual medical care, particularly with respect to the incidence of clincal and laboratory adverse events.
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Ages Eligible for Study:
40 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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