9 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…
A trial investigating the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes
The primary objective is to confirm that treatment with oral semaglutide does not result in an unacceptable increase in cardiovascular risk compared to placebo (rule out 80% excess risk) in subjects with T2D at high risk of cardiovascular events.The…
The objective of the current study is to investigate the possible effects on driving ability of a new anti-depressant (10 mg Lu AA21004) after 1 day of dosing and after 15 days of dosing. These effects will be compared to those of mirtazapine (30 mg…
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…
Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with MCI or mild dementia, both of the Alzheimer*s type.Secondary objectivesTo compare the effects of oral semaglutide…
Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with MCI or mild dementia, both of the Alzheimer*s type.Secondary objectivesTo compare the effects of oral semaglutide…
Primary objectiveTo confirm superiority of oral semaglutide at the maximum tolerated dose* (3 mg, 7 mg or 14 mg) versus placebo on glycaemic control in children and adolescents (age 10 to <18 years) with type 2 diabetes on a background…
The primary objective is to demonstrate that oral semaglutide lowers the risk of major adverse cardiovascular events compared to placebo, both added to standard of care in patients with type 2 diabetes and at high risk of cardiovascular events.The…