Clinical trial NCT00651391 (phase 3, status: terminated)
Conditions: hypercholesterolemia, atherosclerosis
ICD codes: E78.01, E78.00, Z83.42, I67.2, I70.90, I70.91, I70.0, I70.1, I70.8, I25.83
Drugs: ezetimibe + simvastatin, simvastatin, placebo
SMILES: O[C@@H](CC[C@@H]1[C@H](N(C1=O)C1=CC=C(F)C=C1)C1=CC=C(O)C=C1)C1=CC=C(F)C=C1, CC1=CC(O)=CC(C)=C1Cl, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    slow enrollment
  
Eligibility criteria:

        Inclusion Criteria:

          -  Adults (18 years old and older) with primary hypercholesterolemia with a plasma LDL-C
             >=145 mg/dL and <=250 mg/dL, and plasma TG <=350 mg/dL after adequate drug washout.

          -  Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene
             must be maintained on a stable hormone replacement therapy (HRT) or raloxifene regimen
             for at least 6 weeks prior to study entry and throughout the study period.

          -  All subjects must agree to refrain from drinking alcohol or caffeine containing
             beverages for 12 hours prior to each study visit at which a BART assessment is
             performed; be minimally active (eg, avoid excessive physical activity) for 12 hours
             prior to each study visit at which a BART assessment is performed; and be willing to
             observe the NCEP Step I diet, participate in the study, and complete all study-related
             procedures.

        Exclusion Criteria:

          -  Pregnancy or any other situation, condition, or illness that, in the opinion of the
             investigator, may interfere with optimal participation in the study

          -  Smoking, excessive alcohol consumption, underlying disease likely to limit life span
             to less than one year, or known hypersensitivity or any contraindication to
             simvastatin, ezetimibe, or nitroglycerin

          -  Existing hypercholesterolemia for which withholding approved lipid-lowering therapy
             for the duration of the study would be inappropriate

          -  The following concomitant illnesses: congestive heart failure NYHA Class III or IV;
             obstructive cardiomyopathy; uncontrolled cardiac arrhythmias; severe aortic stenosis;
             upper severe aortic stenosis; MI, CABG, or angioplasty within 6 months of study entry;
             uncontrolled hypertension; unstable or severe peripheral artery disease within 3
             months of study entry; unstable angina pectoris; disorders of the hematologic,
             digestive or central nervous systems including cerebrovascular disease and
             degenerative disease that would limit study evaluation or participation; uncontrolled
             or newly diagnosed (within one month of study entry) diabetes mellitus; uncontrolled
             endocrine or metabolic disease known to influence serum lipids or lipoproteins
             (clinically euthyroid subjects on stable replacement doses of thyroid hormone are
             eligible for enrollment); known impairment of renal function (plasma creatinine >2.0
             mg/dL), dysproteinemia, nephrotic syndrome or other renal disease (24-hour urinary
             protein 3+ or 1 gram); hepatobiliary or hepatic disease (subjects with AST or ALT >2
             times the upper limit of reference range will be excluded); HIV positive; and known
             coagulopathy.

          -  Use of certain drugs, foods, or other agents known to alter lipid levels or to cause
             interactions with either ezetimibe or simvastatin