5 results
The purpose of this study is to assess the safety and performance of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transapical Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
Primary objectives of the study are to assess whether the administration of p53-SLP together with the local administration of IFNα is safe and able to induce a strong (directly ex-vivo detectable) p53-specific CD4+ T-cell response. Secondary…
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…
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…
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…