A randomised, controlled, multidose, multicentre, adaptive phase II/III study in infants with proliferating infantile hemangiomas requiring systemic therapy to compare four regimens of propranolol (1 or 3 mg/kg/day for 3 or 6 months) to placebo (dou
A randomised, controlled, multidose, multicentre, adaptive phase II/III study in infants with proliferating infantile hemangiomas requiring systemic therapy to compare four regimens of propranolol (1 or 3 mg/kg/day for 3 or 6 months) to placebo (dou
Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy
A randomised, controlled, multidose, multicentre, adaptive phase II/III study in infants with proliferating infantile hemangiomas requiring systemic therapy to compare four regimens of propranolol (1 or 3 mg/kg/day for 3 or 6 months) to placebo (double blind).
Statut
Status :
Terminé
Type d'étude
Phase II
Age Min.
-
Age Max.
-
Genre
Tous
Aire thérapeutique :
Dermatologie
Maladie :
Hémangiome
Traitement :
Propranolol (Hemangiol®)
Phase :
Phase II
Date de début de l'étude :
24 Février 2010
End date :
05 Novembre 2013
Identifiant de l'essai :
V00400 SB 201
Identifiant EudraCT/CTIS :
2009-013262-84
Identifiant CT.gov :
NCT01056341
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