Hypercholesterolemia Clinical Trial
Official title:
A Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg and Lapaquistat Acetate 100 mg Administered in Combination With Ezetimibe 10 mg vs Ezetimibe 10 mg in Subjects With Primary Dyslipidemia
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with ezetimibe on cholesterol levels in subjects with primary dyslipidemia
In humans, cholesterol is acquired from dietary sources and is produced de novo in the
liver, intestine, and various other tissues. Normally, the balance among cholesterol
synthesis, dietary intake, and degradation is adequate to maintain healthy cholesterol
plasma levels; however, in subjects with hypercholesterolemia, elevation in low-density
lipoprotein cholesterol leads to atherosclerotic deposition of cholesterol in the arterial
walls (atherosclerosis) and subsequent coronary heart disease. Thus, it has been established
that lowering the low-density lipoprotein cholesterol plasma concentrations effectively
reduces cardiovascular morbidity and mortality. Additional lipid risk factors for coronary
heart disease include elevated triglyceride, very low-density lipoprotein cholesterol and
low-density lipoprotein cholesterol levels, and low levels of high-density lipoprotein
cholesterol.
Despite changes in lifestyle and the availability of potent lipid-lowering agents,
cardiovascular disease continues to be the major cause of death in Western Europe and North
America. Serum cholesterol levels exceeding 5 mmol/L (193 mg/dL) are common in adults in
Britain and much of Europe, the United States, Australia, and New Zealand, representing a
serious public health concern.
Currently, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (ie, statins) are the
first-line monotherapies prescribed for the treatment of dyslipidemia, after diet and
therapeutic lifestyle changes alone fail to reduce low-density lipoprotein cholesterol to
desired levels. Statins reduce low-density lipoprotein cholesterol and triglycerides,
increase high-density lipoprotein cholesterol, and improve endothelial function. Treatment
with statins reduces the risk of a vascular event by about 30% in subjects with and without
symptoms of arteriosclerosis; however, many subjects fail to reach recommended levels of
low-density lipoprotein cholesterol reduction after receiving low-dose statins as a
monotherapy. Consequently, the dosage of statins is often increased or an additional
treatment is added; the latter has become an important therapeutic option for achieving
increasingly stringent lipid targets set forth by international therapeutic guidelines.
Ezetimibe is a lipid-lowering compound that selectively inhibits intestinal absorption of
cholesterol at the brush border of the small intestine, leading to a decrease in the
delivery of intestinal cholesterol to the liver. Ezetimibe does not affect the absorption of
triglycerides, fatty acids, bile acids, progesterone, ethinylestradiol, or fat-soluble
vitamins A and D.
TAK-475 (lapaquistat acetate) is a squalene synthase inhibitor currently under development
at Takeda for the treatment of dyslipidemia. This study will evaluate the efficacy and
safety of lapaquistat acetate taken with ezetimibe in subjects with hypercholesterolemia.
Total participation time in this study is expected to be up to 24 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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