LENA WP10
Research type
Research Study
Full title
FOLLOW-UP SAFETY TRIAL IN CHILDREN WITH CHRONIC HEART FAILURE THERAPY RECEIVING ORODISPERSIBLE MINITABLETS OF ENALAPRIL
IRAS ID
192178
Contact name
Michael Burch
Contact email
Sponsor organisation
Ethicare GmbH
Eudract number
2015-002397-21
Clinicaltrials.gov Identifier
P.176/2015, Paediatric Investigation Plan
Duration of Study in the UK
1 years, 5 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.
Enalapril 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.
Within 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.
This study will involve children from age 2 months up to 12 years, all of whom have participated in one of the two feeder studies (WP8 or WP9). The children will be seen and treated at the hospital where their routine clinical care already takes place.
The participation in the study will last for a maximum of 10 months.
The first visit for this study will also be the last visit for the WP8 or WP9 study. There are 4 additional visits at 1 month, 4 months, 7 months and 10 months. At the visits blood and urine sampling, physical examinations, ECGs and Echocardiography will take place.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/1834
Date of REC Opinion
18 Dec 2015
REC opinion
Further Information Favourable Opinion