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Orodispersible Minitablets of Enalapril in Young Children With Heart Failure Due to Congenital Heart Disease (LENA-WP09)
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.
Details
| Lead sponsor | Ethicare GmbH |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | UNKNOWN |
| Enrolment | 50 |
| Start date | 2016-01 |
| Completion | 2017-06 |
Conditions
- Heart Failure
- Congenital Heart Disease
Interventions
- Enalapril Orodispersible Minitablet
Primary outcomes
- Area under the Curve (AUC) of enalapril and its active metabolite enalaprilat after administration of enalapril ODMTs in children with heart failure — 0 hours to 12 hours
Area under the Curve (AUC) of enalapril and enalaprilat are measured at first dose or at any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease (newborn to less than 6 years); descriptive pharmacokinetic investigation - Maximum Concentration (Cmax) of enalapril and its active metabolite — 0 hours to 12 hours
Maximum Concentration (Cmax) of enalapril and enalaprilat are measured at first dose or any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease (newborn to less than 6 years); descriptive pharmacokinetic investigation - Time to Maximum Concentration (Tmax) of enalapril and its active metabolite — 0 hours to 12 hours
Time to Maximum Concentration (Tmax) of enalapril and enalaprilat are measured at first dose or any time during steady state to assess the bioavailability of enalapril ODMTs in young children with heart failure due to congenital heart disease (newborn to less than 6 years); descriptive pharmacokinetic investigation
Countries
Austria, Hungary, Netherlands, Serbia, United Kingdom