Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-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 diagnosis of Fredrickson Type I or V HTG be stable on current maximum tolerated triglyceride lowering therapy have a fasting TG level of at least 880 mg/dL (10 mmol/L) be male or nonpregnant, nonbreastfeeding female. The women in the study must be surgically sterile, postmenopausal or must practice an effective method of birth control must be able to give informed consent or if under the age of 18, parents or legal guardians must give their informed consent meet body weight requirements Exclusion Criteria: Recent heart attack, coronary artery intervention, coronary bypass surgery, or stroke. Patients with class 3 or 4 heart failure Uncontrolled hypothyroidism or other uncontrolled endocrine disease Known, clinically significant eye abnormalities, such as cataracts History of hepatic disease or AST or ALT levels greater than 1.5 x ULN at Visit 1 Alkaline phosphatase greater than 2 times ULN Serum creatinine greater than 2.0 mg/dL Liver cirrhosis and severe liver steatosis Clinically significant infection, malignancy, or psychosis Use of oral anticoagulants or digoxin unless the dose is stable and is regularly monitored Participation in any other investigational study within the last 30 days Breastfeeding or pregnant Current drug or alcohol abuse Serious or unstable medical conditions that would compromise the patient's safety or successful participation in the study Unwillingness to comply with study procedures or unwillingness to cooperate fully