Study title: Open, non controlled, non randomised, unicenter pilot study to investigate the long-term efficacy of Adalat® drops and Adalat® retard 10 mg tablets in children with pulmonary hypertension and with peripheral pulmonary stenosis
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Cardiovascular Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: NIFEPIDINE | |||||
ATC code: C08CA05 | |||||
Document link: Bayer Pharma_Nifedipine_1555_study_synopsis.pdf | |||||
Document date: 2011-09-07 | |||||
Study number: 1555 | |||||
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) |
- | - | - | - | - |