Hypercholesterolemia Clinical Trial
Official title:
An Open-Label Extension Study to Evaluate the Safety and Tolerability of Lapaquistat Acetate in Subjects With Hypercholesterolemia
The purpose of this study is to determine the long-term safety of lapaquistat acetate, once daily (QD), as monotherapy or in combination with other lipid-lowering agents in Subjects with Hypercholesterolemia.
Elevated plasma cholesterol (hypercholesterolemia) and various other plasma lipid imbalances
(dyslipidemias) are major risk factors for coronary heart disease. Normally, the balance
among cholesterol synthesis, dietary intake, and degradation is adequate to maintain healthy
cholesterol plasma levels. However, in patients with hypercholesterolemia, elevation in
low-density lipoprotein cholesterol leads to atherosclerotic deposition of cholesterol in
the arterial walls. Consequently, it has been established that lowering the low-density
lipoprotein cholesterol plasma concentration effectively reduces cardiovascular morbidity
and mortality. As a result of this finding, the National Cholesterol Education Program Adult
Treatment Panel III identifies control of low-density lipoprotein cholesterol as essential
in the prevention and management of coronary heart disease. Additional lipid risk factors
designated by Adult Treatment Panel III include elevated triglycerides, elevated non-high
density lipoprotein cholesterol, and low levels of high-density lipoprotein cholesterol.
Lipoproteins rich in triglycerides, such as very low-density lipoprotein cholesterol, appear
to contribute to atherosclerosis, whereas the apparent protective effect of high-density
lipoprotein cholesterol may be limited at low density lipoprotein concentrations.
Lapaquistat acetate is a squalene synthase inhibitor currently under development at Takeda
for the treatment of dyslipidemia.
Participants in this study have primary hypercholesterolemia and have completed either the
12-week monotherapy protocol 01-04-TL-475-008 (NCT00143663) or the 24-week atorvastatin
add-on study 01-04-TL-475-009 (NCT00143676).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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