The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
796
Unnamed facility
Santa Ana, California, United States
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.
To assess the effects of pactimibe versus placebo, when added to usual medical care:
- on the incidence and the time to first occurrence of
cardiovascular events,
- on inflammatory and oxidative markers, such as serum
high-sensitivity C-reactive protein (hsCRP), plasma
interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and
serum nitrotyrosine.
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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Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Salt Lake City, Utah, United States
Unnamed facility
Seattle, Washington, United States
Unnamed facility
Vancouver, British Columbia, Canada
Unnamed facility
Toronto, Ontario, Canada
...and 27 more locations