Objective Children are often treated as small adults—not as the special patients they are. Regulations exist to encourage the development of drugs and formulation for children. However, off-patent drugs are often administered to children without appropriate formulations or systematic investigations. Therefore, the paediatric use marketing authorisation (PUMA) has been designed.The EMA Paediatric Working Party has prioritized the unmet need for the cardiovascular off-patent drug enalapril in the European paediatric population. Enalapril is an ACE inhibitor commonly used for cardiac failure in children under 1 year of age, although it is not labelled for any condition in patients <20 kg in European countries.Current problems with the use of enalapril in children include: no appropriate formulation and insufficient stability of the liquid soluble formulation for young paediatric patients; insufficient paediatric pharmacokinetic (PK) data for any formulation; insufficient safety data in neonates, infants, and young children; and limited pharmacodynamics (PD) and efficacy data for paediatric cardiological indications.The aim of the LENA (Labeling of Enalapril from Neonates up to Adolescents) project is to address these shortcomings and provide a basis for a future PUMA of enalapril by developing an age-appropriate solid oral formulation suitable for all paediatric subsets; generating PK and PD data; collecting data on the safety of enalapril in young paediatric patients; and providing dose recommendations based on PK/PD modelling and bridging from adult data.The international collaboration of the LENA investigators will provide the required expertise to develop and evaluate drug formulation, investigate dosing, and recruit paediatric patients for clinical trials while respecting current legislation, regulatory considerations, and ethical aspects, with the aim of applying for a PUMA. Fields of science medical and health sciencesclinical medicinepaediatrics Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH.2013.4.2-1 - Investigator-driven clinical trials for off-patent medicines using innovative, age-appropriate formulations and/or delivery systems Call for proposal FP7-HEALTH-2013-INNOVATION-1 See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator HEINRICH-HEINE-UNIVERSITAET DUESSELDORF Address Universitaetsstrasse 1 40225 Dusseldorf Germany See on map Region Nordrhein-Westfalen Düsseldorf Düsseldorf, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Administrative Contact Martina Kuhlmann (Ms.) Links Contact the organisation Opens in new window Website Opens in new window EU contribution € 2 175 012,00 Participants (13) Sort alphabetically Sort by EU Contribution Expand all Collapse all ETHICARE GMBH Germany EU contribution € 774 719,00 Address Am fliederbusch 2 45721 Haltern am see See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Wolfgang Wiedey (Dr.) Links Contact the organisation Opens in new window Website Opens in new window PHARMAPLEX BVBA Belgium EU contribution € 430 500,00 Address Sint hubertuslaan 51 1970 Wezembeek oppem See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Ingrid Klingmann (Dr.) Links Contact the organisation Opens in new window GOTTSEGEN GYORGY ORSZAGOS KARDIOLOGIAI INTEZET Hungary EU contribution € 48 656,00 Address Haller utca 29 1096 Budapest See on map Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Andras Szatmari (Prof.) Links Contact the organisation Opens in new window Website Opens in new window ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM Netherlands EU contribution € 603 207,00 Address Dr molewaterplein 40 3015 GD Rotterdam See on map Region West-Nederland Zuid-Holland Groot-Rijnmond Activity type Higher or Secondary Education Establishments Administrative Contact Ellen Schenk (Ms.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERZITETSKA DECJA KLINIKA Serbia EU contribution € 374 808,00 Address Ul tirsova 10 11000 Beograd See on map Activity type Research Organisations Administrative Contact Milica Bajcetic (Prof.) Links Contact the organisation Opens in new window Website Opens in new window PARACELSUS MEDIZINISCHE PRIVATUNIVERSITAT SALZBURG - PRIVATSTIFTUNG Austria EU contribution € 336 900,00 Address Strubergasse 21 5020 Salzburg See on map Region Westösterreich Salzburg Salzburg und Umgebung Activity type Higher or Secondary Education Establishments Administrative Contact Michael Nake (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Childrens Heart Federation United Kingdom EU contribution € 231 800,00 Address Great eastern street 2-4 EC2A 3NW London See on map Activity type Other Administrative Contact Anne Keatley-Clarke (Ms.) Links Contact the organisation Opens in new window GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG Participation ended Germany EU contribution € 135 234,00 Address Oskar von miller ring 29 80333 Muenchen See on map Region Bayern Oberbayern München, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Birgit Fuchs (Mrs.) Links Contact the organisation Opens in new window Website Opens in new window GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST United Kingdom EU contribution € 266 484,00 Address Great ormond street WC1N 3JH London See on map Region London Inner London — West Camden and City of London Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Claire Newton (Mrs.) Links Contact the organisation Opens in new window KATHOLIEKE UNIVERSITEIT LEUVEN Belgium EU contribution € 240 240,00 Address Oude markt 13 3000 Leuven See on map Region Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven Activity type Higher or Secondary Education Establishments Administrative Contact Elke Lammertyn (Dr.) Links Contact the organisation Opens in new window Website Opens in new window MEDIZINISCHE UNIVERSITAET WIEN Austria EU contribution € 117 753,00 Address Spitalgasse 23 1090 Wien See on map Region Ostösterreich Wien Wien Activity type Higher or Secondary Education Establishments Administrative Contact Ina Michel-Behnke (Prof.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERSITAIR MEDISCH CENTRUM UTRECHT Netherlands EU contribution € 70 214,00 Address Heidelberglaan 100 3584 CX Utrecht See on map Region West-Nederland Utrecht Utrecht Activity type Higher or Secondary Education Establishments Administrative Contact D.M. Looy (Ms.) Links Contact the organisation Opens in new window Website Opens in new window ARTTIC France EU contribution € 194 464,00 Address 39 rue des mathurins 75008 Paris See on map Region Ile-de-France Ile-de-France Paris Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Martin Dietz (Dr.) Links Contact the organisation Opens in new window Website Opens in new window
