A study to evaluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia

Inclusion Criteria

• 1. Prior to any study related procedures being performed, provision of written informed consent from a parent/both parents or guardian and statement of assent from the child or adolescent (if required by Institutional Review Board [IRB] or Independent Ethics Committee [IEC] according to local regulations and guidelines). Study D3561C00004 participants who have had their 18th birthday (adults) will be required to provide written informed consent. Communication should take place between the Investigator, patient/guardian and child/adolescent to confirm understanding and required compliance with the requirements of the study.
• 2. Male and female children and adolescents who were aged 6 to <18 years at the onset of Study D3561C00004 (even if they had their 18th birthday during that study) with:
• - Documentation of genetic testing confirming 2 mutated alleles of the LDL receptor gene locus; and/or
• - Documented untreated LDL C >500 mg/dL (12.9 mmol/L) and TG <400 mg/dL (4.5 mmol/L) and at least 1 of the following criteria:
• o Tendinous and/or cutaneous xanthoma prior to 10 years of age; or
• o Documentation of HeFH in both parents by:
• - genetic and/or
• - clinical criteria
• 3. Negative pregnancy test (b human chorionic gonadotropin analysis) prior to baseline in females of child bearing potential:
• - Female patients of child bearing potential must adhere to a pregnancy prevention method (abstinence, chemical, or mechanical) during the study and 3 months following the last dose;
• - Male patients should refrain from fathering a child (including sperm donation) during the study and up to 3 months following the last dose; and
• 4. Were taking study drug at the end of Study D3561C00004 and are willing to follow all study procedures including adherence to dietary guidelines, study visits, fasting blood draws, and compliance with study treatment regimens.