Clinical trial: Efficacy of Lapaquistat Acetate Alone and With Ezetimibe in Subjects With Primary Dyslipidemia. (NCT00268697)

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.

          -  At Randomization, participants must fulfill the above criteria and also have a mean
             fasting low density lipoprotein cholesterol levels greater than or equal to 3.36
             mmol/L and less than or equal to 5.6 mmol/L and mean triglyceride levels less than or
             equal to 4.52 mmol/L.

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

        Exclusion Criteria:

          -  Has active liver disease or jaundice.

          -  Has a history of cancer, other than basal cell carcinoma, that had been in remission
             for less than 5 years prior to the first dose of study drug.

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

          -  Has a positive hepatitis B surface antigen or hepatitis C virus antibody, as
             determined by medical history and/or the subject's verbal report.

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

          -  Has participated in any other clinical studies with lapaquistat acetate, was
             concurrently participating in another investigational study, 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.

          -  Has a known hypersensitivity or history of intolerance to lapaquistat acetate or
             ezetimibe.

          -  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 and/or
             discontinuation of HMG-CoA reductase inhibitors due to myalgia at any time.

          -  Has uncontrolled hypertension despite medical treatment.

          -  Has inflammatory bowel or any other malabsorption syndrome or had had gastric bypass
             surgery 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 any other serious disease or condition at Visit 1 or Randomization that might
             reduce life expectancy, impaired successful management according to the protocol, or
             make the participant unsuitable to receive study drug.

          -  Has a history of 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;

               -  Multiple risk factors that confer a 10-year risk of coronary heart disease
                  greater than 20% based on the Framingham risk score.
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