drugset / Trial / NCT02652728
Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enalapril | Other / unclassified | 0.25 mg | — |
| Subject | Enalapril | Other / unclassified | 1 mg | — |