Efficacy of Lapaquistat Acetate and Atorvastatin on Blood Cholesterol Levels in Subjects With Primary Hypercholesterolemia

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of lapaquistat acetate, once daily (QD), on lowering cholesterol in subjects already taking atorvastatin.

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

Details

• Lead Sponsor: Takeda
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Female subjects of childbearing potential must not be pregnant as determined by a negative serum human chorionic gonadotropin, lactating, or planning on becoming pregnant, and agrees to use acceptable forms of contraception during the study.

• Must have a mean low density lipoprotein cholesterol value greater than or equal to 2.590 mmol/L (100 mg/dL) for 2 consecutive samples

• Must have a mean triglyceride value less than or equal to 4.516 mmol/L (400 mg/dL) for 2 consecutive samples.

• Has taken a stable dose of atorvastatin (10 to 40 mg)

• Has clinical laboratory evaluations within reference range for the testing laboratory.

• Is willing and able to continue to comply with a standardized low-cholesterol diet.

Exclusion Criteria:

• Has an alanine aminotransferase or aspartate aminotransferase level greater than 1.5 times the upper limit of normal, active liver disease or jaundice.

• Has a serum creatinine level greater than 135 μmol/L (1.5 mg/dL).

• Has a creatine phosphokinase level greater than 3 times the upper limit of normal

• Has diabetes with a hemoglobin A1c level greater than 8% at Visit 1.

• Has a history of cancer in remission for less than 5 years prior to the first dose of study drug.

• Has an endocrine disorder, such as Cushing's syndrome, hyperthyroidism, or inappropriately treated hypothyroidism, affecting lipid metabolism.

• Has a history of myocardial infarction, unstable angina, transient ischemic attacks, cerebrovascular accident, percutaneous coronary intervention, or coronary or peripheral arterial surgery.

• Has a positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or the subject's verbal report.

• Has a positive human immunodeficiency virus status or was taking antiretroviral medications as determined by medical history and/or the subject's verbal report.

• Has had 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 atorvastatin.

• Has a history or presence of clinically significant food allergy that would prevent adherence to the recommended diet.

• Has a known homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia.

• Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.

• Has uncontrolled hypertension

• Has inflammatory bowel disease or any other malabsorption syndrome or has had gastric bypass or any other surgical procedure for weight loss.

• 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 reduce life expectancy, impair successful management according to the protocol, or make the subject an unsuitable candidate to receive study drug.