Clinical trial NCT00532311 (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:

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception from screening throughout the duration of the study and for 30 days
             following the last dose.

          -  Has been on a stable dose of statin for at least 3 months prior to Screening.
             Participants enrolled in Canada, Latin America, and South Africa must be on the
             maximum approved dose of statin (atorvastatin 80 mg, simvastatin 80 mg, rosuvastatin
             40 mg, pravastatin 80 mg, fluvastatin 80 mg, or lovastatin 80 mg).

          -  Prior to Randomization, the participant has a mean low density lipoprotein cholesterol
             level greater than or equal to 100 mg/dL and less than or equal to 190 mg/dL for 2
             consecutive samples.

          -  Prior to Randomization, the subject has mean triglyceride level greater than or equal
             to 400 mg/dL for 2 consecutive samples.

          -  Is willing and able to comply with the recommended, standardized diet.

        Exclusion Criteria:

          -  Has an nine aminotransferase or aspartate aminotransferase level greater than 1.5
             times the upper limit of normal, identified during screening.

          -  Has a serum creatinine greater than 133 mmol/L, identified during screening.

          -  Has a creatine kinase greater than 3 times the upper limit of normal, identified
             during screening.

          -  Has active liver disease or jaundice.

          -  Has taken any bile acid sequestrants [eg, cholestyramine], and intestinal cholesterol
             uptake inhibitors [eg, ezetimibe]) from 30 days before Screening until study
             completion or any fibrates for 6 weeks before Visit 1.

          -  Has a previous history of cancer that has been in remission for less than 5 years
             prior to the first dose of study medication.

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

          -  Has a history of myocardial infarction, angina pectoris, unstable angina, transient
             ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdominal
             aortic aneurysm, coronary angioplasty, coronary or peripheral arterial surgery, or
             multiple risk factors that confer a 10-year risk for cardiovascular heart disease
             greater than 20% based on Framingham risk scoring.

          -  Has a positive hepatitis B surface antigen or hepatitis C virus antibody test, as
             determined by medical history.

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

          -  Has received any investigational medication 30 days prior to screening, (for drugs
             with a long half-life, within a period of less than 5 times the drug's half-life) or
             is participating in an investigational study.

          -  Has received lapaquistat acetate in a previous clinical study or as a therapeutic
             agent.

          -  Has a history or presence of clinically significant food allergy that would prevent
             adherence to the specialized 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 had 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 high alcohol intake within the previous 2
             years.

          -  Has type 1 or 2 diabetes mellitus.