Clinical trial: Tolerability and Efficacy of Rosuvastatin - Fenofibrate Combine Therapy in Korean Patients With Combined Hyperlipidemia (NCT01414803)

Eligibility criteria:
Inclusion Criteria:

          -  mixed hyperlipidemia: total cholesterol levels higher than 220 mg/dL, triglyceride
             (TG) levels between 200 and 500 mg/dL, and low-density lipoprotein (LDL)-cholesterol
             levels higher than 130 mg/dL after 6-week diet/life style change

          -  Men and women who were between 20 and 70 years of age

          -  Having at least one history of: coronary artery disease, cerebrovascular disease or
             transient ischemic attack, peripheral vascular disease, or diabetes mellitus.

          -  Having risk factors at least two of: age ≥45 years in male or ≥55 years in female,
             elevated blood pressure (systolic blood pressure ≥130 mmHg or diastolic blood pressure
             ≥85 mmHg, or treatment of previously diagnosed hypertension), high-density lipoprotein
             (HDL)-cholesterol <40 mg/dL, family history of coronary artery disease at age <55
             years in male or <65 years in female, central obesity (waist circumference ≥90 cm for
             male or ≥80 cm for female), fasting plasma glucose ≥110 mg/dL, or left ventricular
             hypertrophy on electrocardiogram

          -  Written informed consent.

        Exclusion Criteria:

          -  pregnant or breast-feeding

          -  uncontrolled hypertension

          -  uncontrolled diabetes mellitus

          -  thyroid dysfunction

          -  serum transaminase level >2 times the upper limit of normal

          -  history of gall bladder disease

          -  chronic alcoholic

          -  serum creatinine level >1.5 mg/dL

          -  history of myopathy

          -  history of acute myocardial infarction or acute stroke within 3 months before the
             study began

          -  acute or chronic infection or inflammation

          -  history of cancer

          -  history of adverse events associated with test drugs.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 70 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? Entailment