Clinical trial NCT00249899 (phase 3, status: terminated)
Conditions: hypercholesterolemia
ICD codes: E78.01, E78.00, Z83.42
Drugs: lapaquistat acetate and stable statin therapy, stable statin therapy
SMILES: CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1
Reason stopped: 
    overall profile of the compound does not offer significant clinical advantage to patients over
    currently available lipid lowering agents
  
Eligibility 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.