Clinical trial: LDL-Cholesterol Lowering Effect of KB2115 as Add on to Statin (NCT00593047)

Eligibility criteria:
Inclusion Criteria:

          1. Signed informed consent

          2. Males or females aged 18 to 75 years. Female patients must be non-fertile. To be
             considered as non-fertile, females must fulfil the following:

               -  Non-nursing and non-pregnant 12 months prior to enrolment

               -  Not of child bearing potential ie, either documented irreversible surgically
                  sterile (bilateral oophorectomy or hysterectomy is acceptable, but not tubal
                  ligation) or post-menopausal. Post-menopausal is defined as serum
                  follicle-stimulating hormone (FSH) levels in the post-menopausal range combined
                  with amenorrhea for more than 1 year in a woman above 50 years of age, or
                  amenorrhea for more than 2 years below 50 years of age

          3. Patients with hypercholesterolemia treated with stable doses of the below listed lipid
             lowering medication for at least 3 months prior to randomization

               -  Atorvastatin not more than 20 mg/day or

               -  Simvastatin not more than 40 mg/day

          4. LDL-cholesterol > 3.0 mmol/L (Week -1)

          5. Subject able and willing to comply with all study requirements

          6. At randomization, diet as instructed by the investigator during the last 4 weeks prior
             to randomization and willingness to follow these instructions throughout the study

        Exclusion Criteria:

          1. Cholesterol lowering agents other than the defined statins

          2. History of somatic or psychiatric disease/condition, which may interfere with the
             objectives of the study as judged by the investigator

          3. Clinically significant illness or clinically relevant trauma within 2 weeks before the
             administration of the investigational product as judged by the investigator

          4. Chronic (> 3 months) pain condition requiring daily medication with pain killers

          5. Glycosylated haemoglobin (HbA1c) > 7.0%

          6. Diabetes requiring medication other than metformin

          7. Clinically abnormal physical findings and laboratory values as judged by the
             investigator and abnormal resting ECG, eg, QTc interval > 450 msec

          8. Body Mass Index of ≥ 40 kg/m2

          9. Resent history (< 3 month) of stroke or transient ischemic attacks

         10. History of seizure disorder, except febrile convulsions

         11. A current diagnosis of cancer, unless in remission

         12. Blood pressure (BP) of > 160/95 mm Hg

         13. History of cardiac arrhythmia, such as intermittent supraventricular tachyarrhythmia
             and atrial fibrillation

         14. Unstable angina pectoris, myocardial infarction or coronary bypass graft surgery or
             percutaneous coronary intervention < 6 month before randomization

         15. Congestive heart failure New York Heart Association Class > 2

         16. Unstable or severe angina pectoris or peripheral artery disease

         17. Known thyroid disease or thyroid biomarkers (TSH, T3, free T3, T4, free T4) outside
             reference range for normal at enrolment and at baseline

         18. Positive urine pregnancy test in women at enrolment

         19. Use of thyroid replacement therapy and hormone replacement therapy (including
             contraceptive pills) for last 3 months before randomization
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? Entailment