Study title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Cholesterol-Lowering Efficacy and Safety of Simvastatin as an Adjunct to Diet in Children and Adolescents With Familial Hypercholesterolemia
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Cardiovascular Diseases [C14] | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: SIMVASTATIN | |||||
ATC code: C10A A01 | |||||
Document link: | |||||
Document date: | |||||
Study number: PN 163-00 (base) and PN 163-10 (extension) | |||||
EudraCT number: | |||||
Scope of study: Clinical | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
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