7 results
To assess the impact of six IV infusions of 3, 6, or 12 mg/kg of CER-001 or placebo, given at weekly intervals, on atherosclerotic plaque volume, as measured by coronary IVUS.
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…
In this study, we explore the correlation between baseline intratumoral CD8+ cell density and objective response rate (ORR) as well as other biomarker parameters in subjects with unresected stage IIIB to IVM1c melanoma treated with talimogene…
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…
To document the long term safety and efficacy of sarilumab added to DMARDs.
Primary objective is: * To determine the overall survival (OS) benefit of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA.Secundary objectives are:* To determine the PFS benefit of PAG treatment…