Clinical trial: Dose-escalating Safety Study in Subjects on Stable Statin Therapy (NCT00231569)

Eligibility criteria:
Inclusion Criteria:

          -  On a stable dose of >/= 40 mg Simvastatin or atorvastatin daily for >/= 3 months prior
             to baseline and expected to remain on this dose for the remainder of the study

          -  LDL-cholesterol between 2.60 and 5.70 mmol/L (100 and 220 mg/dL), inclusive at
             screening

          -  Females not of childbearing potential.

        Exclusion Criteria:

          -  History of CHD or CHD-equivalent (such as diabetes mellitus, or another clinical form
             of atherosclerotic disease, e.g., peripheral arterial disease, abdominal aortic
             aneurysm, or symptomatic carotid artery disease)

          -  Fasting triglyceride >2.26 mmol/L (200 mg/dL) at screening

          -  Any uncontrolled medical/surgical/psychiatric condition, including conditions that may
             predispose to secondary hypercholesterolemia

          -  Current diagnosis or known history of complement deficiency or abnormality

          -  A positive hepatitis B surface antigen or hepatitis C antibody, or a known positive
             HIV status

          -  Current diagnosis or known history of liver disease, or has an ALT >ULN at screening

          -  Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained
             muscle pain, or has a CPK >ULN at screening

          -  Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin
             that has been adequately treated

          -  The advisability of a subject taking any prescription medication (apart from
             simvastatin or atorvastatin) within 6 weeks prior to screening should be discussed
             with the Isis Medical Monitor

          -  Subject unwilling to discontinue taking alternative/herbal medication for the duration
             of the study

          -  History of drug abuse within 2 years of screening

          -  Subject unwilling to limit alcohol consumption for the duration of the study: male
             subjects to a maximum of 3 drinks (30 g) per day, and <12 drinks (120 g) per week;
             female subjects to a maximum of 2 drinks (20 g) per day, and <8 drinks (80 g) per week

          -  Known allergy or hypersensitivity to simvastatin

          -  Undergoing or has undergone treatment with another investigational drug, biologic
             agent, or device within 3 months, or 3 half lives, prior to screening, whichever is
             longer
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 65 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