Clinical trial: Efficacy of Lapaquistat Acetate and Simvastatin in Subjects With Primary Dyslipidemia. (NCT00256178)

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 a documented history of dyslipidemia with or without cardiovascular risk factors
             but without type 1 or 2 diabetes.

          -  Is on a stable dose of simvastatin, either 20 or 40 mg, for at least 4 weeks prior to
             Screening.

          -  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 annine 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? Entailment