Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy

Exclusion Criteria

• •1. Uncontrolled hypertension
• •2. History of chronic renal insufficiency
• •3. History of biopsy proven cirrhosis or abnormal liver function tests (LFTs) at screening
• •4. Any major surgical procedure occurring \< 3 months prior to the screening visit
• •5. Cardiac insufficiency
• •6. Previous organ transplantation
• •7. History of a non-skin malignancy within the previous 3 years
• •8. Patients who are not able to limit their alcohol intake
• •9. Participation in an investigational drug study within 6 weeks prior to the screening visit
• •10. Known significant gastrointestinal bowel disease
• •11. Nursing mothers
• •12. Serious or unstable medical or psychological conditions
• •13. Requirement for certain prohibited medications known to be potentially hepatotoxic
• •14. Use of strong or moderate inhibitors of CYP3A4
• •15. Use of simvastatin at doses \>10 mg per day
• •16. Documented diagnosis of any liver disease