drugset / Trial / NCT02652728

Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy

NCT02652728

Phase 2/3 Unknown 50 enrolled Ethicare GmbH
NaSingle-groupOpen-labelTreatment

Summary

Paediatric clinical trial in 50 children, from 1 month to less than 12 years of age, suffering from heart failure due to dilated cardiomyopathy, 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

EvaluationDrugModalityDoseRoute
Subject Enalapril Other / unclassified 0.25 mg
Subject Enalapril Other / unclassified 1 mg