Clinical trial: Switching to Rosuvastatin Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Atorvastatin in Patients With Hypercholesterolemia and Risk Factors (P03708) (NCT00651378)

Eligibility criteria:
Inclusion Criteria:

          -  18 years to 75 years of age;

          -  Stabilized on atorvastatin 10 mg daily and by subject reported history had taken at
             least 80% of daily doses for the 4 weeks preceding Visit 1;

          -  LDL-C concentration greater than or equal to 2.5 mmol/L to less than or equal to 160
             mg/dL (less than or equal to 4.1 mmol/L) based on blood specimens taken at Visit 1,
             using the Friedewald calculation as described in the Protocol,Section 8.8. (The lipid
             profiles at Visit 3 (baseline) and all subsequent visits were kept "blinded" until
             data analysis);

          -  Triglyceride concentration of less than 350 mg/dL (less than 3.99 mmol/L) based on
             blood specimens taken at Visit 1;

          -  Documented atherosclerotic disease, CHD, or diabetes mellitus;

          -  Liver transaminases (ALT, AST) less than 50% above the upper limit of normal, with no
             active liver disease, and CPK less than 50% above the upper limit of normal as tested
             in blood specimens taken at Visit 1;

          -  Clinical laboratory tests (CBC, blood chemistries, urinalysis) taken at Visit 1 must
             have been within normal limits or clinically acceptable to the Investigator;

          -  Had been previously prescribed a cholesterol lowering diet and exercise program at
             least 4 weeks prior to Visit 1 and had been advised to continue the same diet and
             exercise program during the study;

          -  Reported a stable weight history for at least 4 weeks prior to randomization at Visit
             3 (baseline visit);

          -  Women receiving hormonal therapy, including hormone replacement, any estrogen
             antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose
             and regimen for at least 8 weeks and willing to continue the same regimen for the
             duration of the study;

          -  Women of childbearing potential (included women who were less than 1 year
             postmenopausal and women who became sexually active) must have been using an
             acceptable method of birth control (for example, hormonal contraceptive, medically
             prescribed IUD, condom in combination with spermicide) or been surgically sterilized
             (for example, hysterectomy or tubal ligation).

          -  Free of any clinically significant diseases other than hyperlipidemia, CHD, or
             diabetes mellitus that would interfere with study evaluations;

          -  Understood and were able to adhere to the dosing and visit schedules, and demonstrated
             their willingness to participate in the study and comply with its procedures by
             signing a written informed consent.

        Exclusion Criteria:

          -  Consumption greater than 14 alcoholic drinks per week. (A drink is: a can of beer [1/2
             pint or 250 ml], glass of wine, or single measure of spirits);

          -  Any condition or situation which, in the opinion of the Investigator, might have posed
             a risk to the subject or interfered with participation in the study;

          -  Body mass index (BMI) >= 35 Kg/m^2 at Visit 2 (Screening);

          -  Women who were pregnant or nursing;

          -  Failure to observe the designated washout periods for any of the prohibited
             medications
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.
Subject must be at most 75 Years

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? Contradiction