Safety and Efficacy of Lapaquistat Acetate Taken Alone and With Atorvastatin in Subjects With Primary Dyslipidemia

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

Summary

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.

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

Details

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

Criteria

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.