9 results
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 paediatric patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with DCM.Secondary:1. To demonstrate…
To demonstrate that ofatumumab is superior to teriflunomide in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS
Primary objective:- To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple…
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 determine the efficacy of SAR442168 compared to a daily dose of 14 mgteriflunomide (Aubagio) in decreasing relapses in RMS.Secondary:1. To evaluate safety, tolerability, and efficacy of SAR442168 compared to placebo on clinical endpoints…
The goal of the fenebrutinib development program in MS is to evaluate the benefits and risks of fenebrutinib treatment across the spectrum of patients with MS. Based on the existing toxicology, pharmacology, and clinical experience with fenebrutinib…
Primary Objective:To evaluate the effect of sonlicromanol on motor symptom severity in children with genetically confirmed mitochondrial disease affecting oxidative phosphorylation during a 6 month treatment period (GMFM).
The purpose of the study is to provide efficacy, safety and tolerability data for remibrutinib to support regulatory approval worldwide as a treatment for relapsing multiple sclerosis (RMS). Two identical Phase III trials (CLOU064C12301 and…