Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
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The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
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Ages Eligible for Study:
8 Years to 70 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
In order to participate in this study, patients must not meet any of the following exclusion criteria: