LENA WP8
Research type
Research Study
Full title
ORODISPERSIBLE MINITABLETS OF ENALAPRIL IN CHILDREN WITH HEART FAILURE DUE TO DILATED CARDIOMYOPATHY
IRAS ID
190138
Contact name
Wolfgang Wiedey
Contact email
Sponsor organisation
Ethicare GmbH
Eudract number
2015-002335-17
Clinicaltrials.gov Identifier
P/176/2015, Paediatric Investigation Plan number
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Enalapril maleate has established medical use in children above 20kg (about 6 years of age) and has been marketed in Europe since 1983. In children below 20kg of weight, enalapril is widely used off-label on the basis of a few clinical studies. Its safety and efficacy is well understood, especially in the older population and is regarded as gold standard therapy in heart failure.\n\nEnalapril is currently available only in the form of tablets in the European Union. Although oral liquids from crushed tablets are commonly used for infants and young children, they are less portable than solids. Also, due to problems when the drug is dissolved, solid oral paediatric dosage forms are needed. \n\nWithin the LENA project, the new dosage form of so called orodispersible minitablets (ODMTs) will be used as a vehicle for enalapril. ODMTs are small sized tablets (2mm in diameter) which immediately disintegrate in the mouth. Hence, accidental particle inhalation or in the worst case aspiration pneumonia can be prevented. \n\nThis study will involve children from age 1 month up to 12 years, all of whom have heart failure due to dilated cardiomyopathy. The children will be seen and treated at the hospital where their routine clinical care already takes place. \n\nThe participation in the study will last between 3 days and 8 weeks, depending on how many does titrations are needed. \n\nThe children will attend for a maximum of 11 visits (depending on dose titration) at which physical examinations, ECGs, Echocardiography, blood and urine sampling and continuous blood pressure monitoring will take place.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/1832
Date of REC Opinion
18 Dec 2015
REC opinion
Further Information Favourable Opinion