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).
Status
Status :
Completed
Type of study
Phase II
Min. Age
-
Max. Age
-
Gender
All
Therapeutic area :
Dermatology
Disease :
Hemangioma
Study medication :
Propranolol (Hemangiol®)
Phase :
Phase II
Start Date :
24 February 2010
End date :
05 November 2013
Study ID :
V00400 SB 201
EudraCT/CTIS number :
2009-013262-84
CT.gov Number :
NCT01056341
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