Study title: "Open label, phase III, dose titration, multicenter study to assess the efficacy and safety of fluvastatin sodium capsules and fluvastatin sodium extended-release tablets (20, 40 and 80 mg) given orally at bedtime for 114 weeks in pediatric patiens with heterozygous familial hypercholesterolemia"
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Cardiovascular Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report, Please see report, Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: FLUVASTATIN | |||||
ATC code: C10AA04 | |||||
Document link: | |||||
Document date: | |||||
Study number: CXUO320B 2301 | |||||
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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