6 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 patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with CHD. Secondary:1. To demonstrate safety 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…
The purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled, dubbleblind clinical trial to investigate the use of methylfenidate, rivastigmine or haloperidol in hypoactive ICU-delirium. Secondary we will try to…
To assess the efficacy of haloperidol to resolve delirium in adult critically ill patients and thereby render the patient awake and non-delirious.
PART B (FL phase IIb *PARADIGME*):Primary objective:Randomised section of Part B- To evaluate the efficacy of the *40/15* dose regimen (40 mg lilotomab / 15 MBq/kg Betalutin) compared with *100/20* dose regimen (100 mg/m2 lilotomab/ 20 MBq/kg…