The purpose of this study is to evaluate the overall safety of Lapaquistat Acetate, once
daily (QD), by itself or in combination with atorvastatin in subjects with primary
dyslipidemia.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Has a confirmatory central laboratory result with low density lipoprotein cholesterol
greater than or equal to 3. 37 mmol/L and less than 5. 69 mmol/L, and triglyceride less
than 4. 52 mmol/L.
- Females of child-bearing age must have undergone surgical sterilization,
hysterectomy, tubal ligation, or bilateral oophorectomy; other female subjects must
have been postmenopausal.
- Must be in good physical and mental health as determined by a physician on the basis
of medical history, physical examination, and laboratory results.
- Has a fasting low density lipoprotein cholesterol level greater than or equal to 3. 37
mmol/L and less than 4. 92 mmol/L, and a triglyceride value less than 4. 52 mmol/L.
Exclusion Criteria:
- Coronary Heart Disease or Coronary Heart Disease-risk factors comprised of:
- Diabetes mellitus type 1 or 2.
- History or presence of myocardial infarction, angina pectoris, unstable angina,
coronary angioplasty, coronary or peripheral arterial surgery (bypass graft),
aortic aneurysm, transient ischemic attacks, or cerebrovascular accident.
- A body mass index less than 15 or greater than 35.
- A history or presence of:
- Drug abuse or a history of alcohol abuse within the 2 years previous to
screening.
- Uncontrolled hypertension despite medical treatment
- Thyroid disease, particularly hyperthyroidism or subjects whose thyroid
replacement therapy was initiated within the previous 3 months.
- Human immunodeficiency virus-positive status, or hepatitis B or C infection.
- Malignancy, except subjects whose malignancy had been diagnosed as stage I basal
or squamous cell carcinoma.
- Heterozygous or homozygous familial hypercholesterolemia or known type III
hyperlipoproteinemia.
- Fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain and/or
discontinuation of statins due to myalgia.
- Trauma to the eye or eye irradiation; glaucoma; iritis; uveitis; prior
intraocular surgery, laser surgery to the iris, retinal photocoagulation, or
laser trabeculoplasty; corneal opacification or other medial opacities; or had
undergone LASIK refractive surgery within 6 months prior to screening.
- A clinically significant food allergy that would prevent adherence to the
specialized diet.
- Any other serious disease or condition that might have affected life expectancy or
made it difficult to successfully manage and monitor the subject according to the
protocol.
- Has a known hypersensitivity or history of adverse reaction to atorvastatin or to
lapaquistat acetate.
- Is taking part in another investigational study or had been participating in an
investigational study within the 30 days prior to Screening Visit 1.
- Has an alanine aminotransferase or aspartate aminotransferase level greater than 2
times the upper limit of normal, active liver disease, jaundice, serum creatinine
greater than 135 μmol/L (1. 5 mg/dL), or creatine kinase greater than 3 times the
upper limit of normal.
Buenos Aires, Argentina
Ciudad Autonoma de Buenos Aires, Argentina
Cordoba, Argentina
La Plata, Argentina
Moron, Argentina
Pilar, Argentina
Rosario, Argentina
Salta, Argentina
Santa Fe, Argentina
Santiago de Chile, Chile
Brno, Czech Republic
Olomouc, Czech Republic
Praha, Czech Republic
Tartu, Estonia
Berlin, Germany
Freiburg, Germany
Görlitz, Germany
Hamburg, Germany
Mannheim, Germany
Munich, Germany
Mönchengladbach, Germany
Schwerin, Germany
Budapest, Hungary
Debrecen, Hungary
Esztergom, Hungary
Gyula, Hungary
Győr, Hungary
Kecskemét, Hungary
Warszawa, Hungary
Riga, Latvia
Kaunas, Lithuania
Vilnius-21, Lithuania
Vilnius, Lithuania
Distrito Federal, Mexico
Guadalajara, Mexico
Jalisco, Mexico
Mexico City, Mexico
San Luis Potosi, Mexico
Zapopan, Mexico
Es Velp, Netherlands
Groningen, Netherlands
Leiden, Netherlands
Rotterdam, Netherlands
Zoetermeer, Netherlands
Lima, Peru
Bialystok, Poland
Bydgoszcz, Poland
Gdansk, Poland
Gorzow Wielkopolski, Poland
Grudziadz, Poland
Plonsk, Poland
Torun, Poland
Wloclawek, Poland
Wroclaw, Poland
Moscow, Russian Federation
Saint-Petersburg, Russian Federation
Saratov, Russian Federation
Komárno, Slovakia
Kosice, Slovakia
Levice, Slovakia
Cape Town, South Africa
Johannesburg, South Africa
Parow, South Africa
Western Cape, South Africa
Birmingham, Alabama, United States
Mobile, Alabama, United States
Northport, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Sierra Vista, Arizona, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Rancho Cucamonga, California, United States
Santa Rosa, California, United States
Golden, Colorado, United States
Truro, Cornwall, United Kingdom
Coral Gables, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Sarasota, Florida, United States
West Palm Beach, Florida, United States
Dunwoody, Georgia, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Elk Grove Village, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Waterloo, Iowa, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Louisville, Kentucky, United States
Blackpool, Lancashire, United Kingdom
Bolton, Lancashire, United Kingdom
New Orleans, Louisiana, United States
Flint, Michigan, United States
Edina, Minnesota, United States
St. Louis, Missouri, United States
Omaha, Nebraska, United States
Ship Bottom, New Jersey, United States
Rochester, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Statesville, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinatti, Ohio, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Tipton, Pennsylvania, United States
Anderson, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
Guildford, Surrey, United Kingdom
Cordova, Tennessee, United States
Morristown, Tennessee, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Texarkana, Texas, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Lakewood, Washington, United States