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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or with simvastatin on cholesterol levels in treating patients with elevated cholesterol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Simvastatin

Criteria

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.