congenital hemangiomas MedDRA version: 12.1 Level: LLT Classification code 10018818 Term: Haemangioma congenital
Conditions
Interventions
Product Name: propranololo sciroppo prodotto galenico
Pharmaceutical Form: Syrup
INN or Proposed INN: Propranolol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentrat
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients > 4 weeks of age and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Hypersensitivity to propranolol in first degree relatives - Severe clinical conditions that contraindicate the inclusion in the study - Mellitus diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of systemic propranolol in the treatment of congenital hemangiomas, during the first months of life.;Secondary Objective: The secondary objective is to evaluate the tolerability of systemic propranolol in the treatment of congenital hemangiomas, during the first months of life;Primary end point(s): Evaluation of the efficacy of systemic propranolol in the treatment of congenital hemangiomas, during the first months of life | — |
Countries
Italy
Outcome results
None listed