Clinical trial: A 16 Week Comparative Study of Fenofibrate Versus Ezetimibe as Add-on Therapy to Atorvastatin (NCT00195793)

Eligibility criteria:
Inclusion Criteria:

          -  Subject is >= 18 years of age, any race, and any gender.

          -  Subjects must have the following fasting parameters:

               -  LDL-C > 100 mg/dL and < 190 mg/dL.

               -  TG level >= 175 mg/dL and < 1000 mg/dL.

               -  HDL-C < 40 mg/dL (men) and < 50 mg/dL (women).

          -  Subjects must have one or more of the following:

               -  Treated or untreated hypertension defined as blood pressure (BP)

               -  130 mmHg >= 85 mmHg (systolic / diastolic).

               -  Waist circumference > 88 cm (35 inches) for women or > 102 cm (40 inches) for
                  men.

               -  Fasting glucose defined as >= 100 mg/dL but <= 125 mg/dL.

          -  Subject has, in the opinion of the investigator, a life expectancy greater than 6
             months.

          -  Female subjects must have a negative pregnancy test prior to study enrollment.

          -  Female subjects of child bearing potential must agree to practice an effective barrier
             method of birth control for the duration of the study.

          -  Subject must be willing to observe the Step I Diet recommended by the NCEP throughout
             the study.

          -  Subject must be willing to participate in the study and to complete all follow-up
             assessments.

        Exclusion Criteria:

          -  Subject has a known hypersensitivity to fenofibrate, ezetimibe, or atorvastatin

          -  Subject has been previously enrolled in this study.

          -  Subject has used an investigational drug within 30 days of study entry.

          -  Subject has been diagnosed with Type I or Type II Diabetes Mellitus or is currently
             being treated with anti-diabetic medication, or has a fasting glucose >= 126 mg/dL.

          -  Subject has a history of pancreatitis or cholelithiasis or a history of gastric or
             duodenal ulcer within 3 months of study entry.

          -  Subject has hematologic, digestive, or central nervous system disorder including
             cerebrovascular disease or degenerative disease that would limit study evaluation or
             participation.

          -  Subject has had a myocardial infarction, coronary bypass surgery, or angioplasty
             within 6 months of study entry.

          -  Subject has unstable or severe peripheral artery disease within 3 months of study
             entry.

          -  Subject has unstable angina pectoris or uncontrolled cardiac arrhythmias.

          -  Subject has congestive heart failure (CHF) as defined by NYHA Class III or IV

          -  Subject has coagulopathy (PT or PTT > 1.25 times control).

          -  Subject has known impairment of renal function (serum creatinine > 1.5 mg/dL),
             dysproteinemia, nephrotic-range proteinuria, or other renal disease.

          -  Subject has active or chronic hepatobiliary or hepatic disease (subjects with AST or
             ALT > 2 times the upper limit of the central laboratory reference range).

          -  Subject is pregnant or lactating.

          -  Subject is receiving hormonal therapy.

          -  Subject has a known history of thyroid disease or other endocrine abnormality.

          -  Subject has a history of diagnosed hereditary or acquired myopathy.

          -  Subject is known to be HIV positive.

          -  Subject has a history of mental instability, drug or alcohol (as defined by greater
             than 14 drinks per week) abuse, or subject has been treated for severe psychiatric
             illness, which, in the opinion of the investigator, may interfere with optimal
             participation in the study.

          -  Subject has received a solid organ transplant.

          -  Subject has a clinically significant, unstable, uncontrolled disease that could be
             adversely affected by study participation.

          -  Subject is unwilling or unable to consent to enter the study.

          -  Subject is, in the opinion of the investigator, unable to comply with the requirements
             of the study protocol or is unsuitable for the study for any reason.
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 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? 0