Efficacy of Lapaquistat Acetate Alone or Combined With High-Dose Statin Therapy in Subjects With Hypercholesterolemia

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Takeda
• Treatments: Atorvastatin; Atorvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; 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.

• The subject had taken the highest recommended dose of a statin for at least 4 weeks prior to Visit 1.

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.

• The subject had a known hypersensitivity or history of adverse reaction to atorvastatin, simvastatin or rosuvastatin.

• 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.