Study title: A 24-week open – label randomized cross-over study to monitor the plasma phenylalanine concentrations of subjects with phenylketonuria, aged 8 to 30 years, using Aminogran 1g tablets supplement to manage at least 50% of their protein substitute requirements or using standard diet supplement (Aminogran 1g tablets excluded)
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Congenital, Hereditary, and Neonatal Diseases and Abnormalities | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
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Active substance: NUTRIENTS WITHOUT PHENYLALANINE | |||||
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Study number: ARCE01E3028 | |||||
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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 | Y |