Orodispersible Minitablets of Enalapril in Young Children With Heart Failure Due to Congenital Heart Disease

Summary

Paediatric clinical trial in 50 children, from newborn to less than 6 years of age, suffering from heart failure due to congenital heart disease, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.

Timeline

Start

2016-01

Primary completion

2017-06

Completion

2017-06

Drugs

Indications