Study title: A 30-Week, Forced-titration and Randomised, Crossover, Multicentre, Multinational Trial to Evaluate the Efficacy and Safety of rosuvastatin and Atorvastatin in Subjects with Homozygous Familial Hypercholesterolaemia (4522IL/0054): Full Report of the First 18 Weeks (forced-titration) and Last 12 Weeks of Treatment (crossover period) for Efficacy and for Safety
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Nutritional and Metabolic Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: ROSUVASTATIN CALCIUM | |||||
ATC code: | |||||
Document link: Study 4522IL0054_CSR Synopsis.pdf | |||||
Document date: 2011-11-23 | |||||
Study number: 4522IL0054 | |||||
EudraCT number: | |||||
Scope of study: | |||||
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) |
- | - | - | Y | Y |