Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy

Inclusion Criteria: In order to participate in this study, patients must meet all of the following inclusion criteria: be between 8 and 70 years old with a diagnosis of HoFH; be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments; have an appropriate calculated, fasting LDL-C levels and an appropriate triglyceride (TG) level; be male or nonpregnant, nonlactating female; give informed consent; and meet body weight and height requirements. Exclusion Criteria: In order to participate in this study, patients must not meet any of the following exclusion criteria: recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident; uncontrolled hypothyroidism or other uncontrolled endocrine disease; known, clinically significant eye abnormalities (e.g., cataracts); appropriate serum creatinine phosphokinase levels; history of liver disease or liver enzyme levels above appropriate levels; alkaline phosphatase above appropriate levels; liver cirrhosis and severe liver steatosis; clinically significant infection, malignancy, or psychosis; use of oral anticoagulants or digoxin, unless the dose has been stable for 4 weeks; participation in any other investigational study, including device or observational studies, within 30 days; lactating or have a positive serum pregnancy test; history of or current drug or alcohol abuse; or unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator.