Efficacy of Lapaquistat Acetate Alone or Combined With Simvastatin in Subjects With Hypercholesterolemia

Inclusion Criteria: * Woman of childbearing potential can not to be pregnant, lactating, not planning on becoming pregnant, and agree to use acceptable forms of contraception throughout the course of the study. * Prior to Randomization, has a low-density lipoprotein cholesterol level mean greater than or equal to 3.37 mmol/L and less than or equal to 5.70 mmol/L. * Prior to Randomization, has a mean triglyceride level less than or equal to 4.52 mmol/L (400 mg/dL). * Has clinical laboratory evaluations including clinical chemistry, hematology, and urinalysis within the defined reference range. Exclusion Criteria: * Has an alanine aminotransferase or aspartate aminotransferase level of greater than 1.5 times the upper limit of normal, active liver disease or jaundice. * Has a serum creatinine of greater than 133 μmol/L. * Has a creatine kinase greater than 3 times the upper limit of normal. * Has type 1 or 2 diabetes mellitus. * Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. * Has an endocrine disorder, such as Cushing syndrome, hyperthyroidism, or inappropriately treated hypothyroidism, affecting lipid metabolism. * Has a history of myocardial infarction, angina pectoris, transient ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdominal aortic aneurysm, coronary revascularization or multiple factors that conferred a 10-year risk for coronary heart disease greater than 20% based on Framingham risk scoring. * Has a positive hepatitis B surface antigen, or antibody to hepatitis C virus, as determined by medical history and/or subject's verbal report. * Has a positive human immunodeficiency virus status or was taking antiretroviral medications, as determined by medical history. * Has exposure to lapaquistat acetate in other studies, was participating in another investigational study, or had participated in an investigational study within the past 30 days or, for drugs with a long half-life, within a period of less than 5 times the drug's half-life. Has a known hypersensitivity or history of adverse reaction to simvastatin. * Has a known hypersensitivity or history of adverse reaction to simvastatin. * Has a history or presence of clinically significant food allergy that would prevent adherence to the recommended diet. * Has a known heterozygous or homozygous familial hypercholesterolemia or known Type III hyperlipoproteinemia (familial dysbetalipoproteinemia). * Has fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain. * Has uncontrolled hypertension * Has inflammatory bowel disease, any other malabsorption syndrome, or had gastric bypass or any other surgical procedure for weight loss. * Is unwilling or unable, in the opinion of the investigator, to comply with the protocol or scheduled appointments. * Has a history of drug abuse or a history of alcohol abuse within the past 2 years. * Has any other serious disease or condition that might reduced life expectancy, impaired successful management according to the protocol, or make the participant an unsuitable candidate to receive study medication.