Study title: A) Open non-comparative pilot study B) randomized, double-blind, parallel study using Amipaque (metrizamide) 300 mgI/ml as comparison in pediatric urography to assess the safety, tolerability and image effectiveness of iohexol 300 mgI/ml firstly in an open study and later compared to Amipaque 300 mgI/ml.Applicant's study report
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: IOHEXOL | |||||
ATC code: V08AB02 | |||||
Document link: Copy of List of studies Omnipaque- pediatric.xls | |||||
Document date: 2015-01-23 | |||||
Study number: Iohexol No. 34 | |||||
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 | Y | Y |