Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy (LENA-WP08)

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.


Study Type: Interventional
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy
Estimated Enrollment: 50
Study Start Date: January 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Drug administration