The purpose of this study is to determine the efficacy of lapaquistat acetate, once daily
(QD), on lowering cholesterol in subjects already taking atorvastatin.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Birmingham, Alabama, United States
Northport, Alabama, United States
Sierra Vista, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Searcy, Arkansas, United States
Anaheim, California, United States
Carmichael, California, United States
Chula Vista, California, United States
Escondido, California, United States
Pismo Beach, California, United States
Santa Rosa, California, United States
Golden, Colorado, United States
Waterbury, Connecticut, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Pembroke Pines, Florida, United States
West Palm Beach, Florida, United States
Honolulu, Hawaii, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Bloomington, Indiana, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Waterloo, Iowa, United States
Arkansas City, Kansas, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Auburn, Maine, United States
Livonia, Michigan, United States
Edina, Minnesota, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Edison, New Jersey, United States
Margate, New Jersey, United States
New Hyde Park, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Altoona, Pennsylvania, United States
Downingtown, Pennsylvania, United States
Sellerville, Pennsylvania, United States
Tipton, Pennsylvania, United States
Warwick, Rhode Island, United States
Charleston, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
Chattanooga, Tennessee, United States
Morristown, Tennessee, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Euless, Texas, United States
San Antonio, Texas, United States
The Colony, Texas, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Renton, Washington, United States
Madison, Wisconsin, United States