Study title: Dose ranging, safety and tolerability trial of felodipine ER in pediatric patients; a multicenter, double-blind, placebo-controlled, randomized, parallel group trial with an open-label extension
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: FELODIPINE | |||||
ATC code: | |||||
Document link: US No. 216 OL (SH-FEH-0024) CSR Synopsis.pdf | |||||
Document date: 2011-10-19 | |||||
Study number: US No. 216 (SH-FEH-0024) | |||||
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) |
- | - | - | - | Y |