5 results
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in paediatric patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with DCM.Secondary:1. To demonstrate…
- To examine the safety and feasibility (i.e. technical end result) of using OviTex core PGA during VMR - To assess perioperative complications- To assess 90-day morbidity
Primary:To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).Secondary:1. To describe the acceptability and palatability of enalapril ODMTs..2. To collect additional information about pharmacokinetics and pharmacodynamics of…
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with CHD. Secondary:1. To demonstrate safety of…
Main study parameter/endpoint phase II- Post-operative morbidity measured by reoperations, reinterventions, re-admissions, serious adverse events, Clavien Dindo classification and CTS classification. - The rate of rectal prolapse recurrence and…