LENA

Labeling of Enalapril from Neonates up to Adolescents

 Coordinatore HEINRICH-HEINE-UNIVERSITAET DUESSELDORF 

 Organization address address: UNIVERSITAETSSTRASSE 1
city: DUSSELDORF
postcode: 40225

contact info
Titolo: Ms.
Nome: Martina
Cognome: Kuhlmann
Email: send email
Telefono: +49 2118112574
Fax: +49 2118112422

 Nazionalità Coordinatore Germany [DE]
 Totale costo 7˙438˙230 €
 EC contributo 5˙999˙991 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2013-INNOVATION-1
 Funding Scheme CP-FP
 Anno di inizio 2013
 Periodo (anno-mese-giorno) 2013-11-01   -   2018-10-31

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    HEINRICH-HEINE-UNIVERSITAET DUESSELDORF

 Organization address address: UNIVERSITAETSSTRASSE 1
city: DUSSELDORF
postcode: 40225

contact info
Titolo: Ms.
Nome: Martina
Cognome: Kuhlmann
Email: send email
Telefono: +49 2118112574
Fax: +49 2118112422

DE (DUSSELDORF) coordinator 2˙093˙410.00
2    ETHICARE GMBH

 Organization address address: AM FLIEDERBUSCH 2
city: HALTERN AM SEE
postcode: 45721

contact info
Titolo: Dr.
Nome: Wolfgang
Cognome: Wiedey
Email: send email
Telefono: +49 2596 3574

DE (HALTERN AM SEE) participant 774˙719.00
3    ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

 Organization address address: 's Gravendijkwal 230
city: ROTTERDAM
postcode: 3015CE

contact info
Titolo: Ms.
Nome: Ellen
Cognome: Schenk
Email: send email
Telefono: +31 107044876

NL (ROTTERDAM) participant 673˙421.00
4    PHARMAPLEX BVBA

 Organization address address: SINT HUBERTUSLAAN 51
city: WEZEMBEEK OPPEM
postcode: 1970

contact info
Titolo: Dr.
Nome: Ingrid
Cognome: Klingmann
Email: send email
Telefono: +32 27843693
Fax: +32 2 784 30 66

BE (WEZEMBEEK OPPEM) participant 430˙500.00
5    GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG GAB O

 Organization address address: Oskar-von-Miller-Ring 29
city: MUENCHEN
postcode: 80333

contact info
Titolo: Mrs.
Nome: Birgit
Cognome: Fuchs
Email: send email
Telefono: +49 8928810414
Fax: +49 8928810420

DE (MUENCHEN) participant 411˙300.00
6    UNIVERZITETSKA DECJA KLINIKA

 Organization address address: UL TIRSOVA 10
city: BEOGRAD
postcode: 11000

contact info
Titolo: Prof.
Nome: Milica
Cognome: Bajcetic
Email: send email
Telefono: +38 111 3643388
Fax: +38 111 3643397

RS (BEOGRAD) participant 374˙808.00
7    PARACELSUS MEDIZINISCHE PRIVATUNIVERSITAT SALZBURG

 Organization address address: STRUBERGASSE 21
city: SALZBURG
postcode: 5020

contact info
Titolo: Dr.
Nome: Michael
Cognome: Nake
Email: send email
Telefono: +43 662 442002 1200
Fax: +43 662 442002 1209

AT (SALZBURG) participant 336˙900.00
8    Great Ormond Street Hospital for Children NHS Trust

 Organization address address: Great Omond Street
city: LONDON
postcode: WC1N 3JH

contact info
Titolo: Mrs.
Nome: Claire
Cognome: Newton
Email: send email
Telefono: +44 0207813 5501

UK (LONDON) participant 266˙484.00
9    KATHOLIEKE UNIVERSITEIT LEUVEN

 Organization address address: Oude Markt 13
city: LEUVEN
postcode: 3000

contact info
Titolo: Dr.
Nome: Elke
Cognome: Lammertyn
Email: send email
Telefono: +32 16 32 06 21

BE (LEUVEN) participant 240˙240.00
10    Childrens Heart Federation

 Organization address address: Great Eastern Street 2-4
city: LONDON
postcode: EC2A 3NW

contact info
Titolo: Ms.
Nome: Anne
Cognome: Keatley-Clarke
Email: send email
Telefono: +44 2074220630
Fax: +44 2072472087

UK (LONDON) participant 231˙800.00
11    MEDIZINISCHE UNIVERSITAET WIEN

 Organization address address: SPITALGASSE 23
city: WIEN
postcode: 1090

contact info
Titolo: Prof.
Nome: Ina
Cognome: Michel-Behnke
Email: send email
Telefono: +43 1404003217
Fax: +43 1404003417

AT (WIEN) participant 117˙753.00
12    GOTTSEGEN GYORGY ORSZAGOS KARDIOLOGIAI INTEZET

 Organization address address: Haller utca 29
city: BUDAPEST
postcode: 1096

contact info
Titolo: Prof.
Nome: Andras
Cognome: Szatmari
Email: send email
Telefono: +36 302301463
Fax: +36 12157441

HU (BUDAPEST) participant 48˙656.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

appropriate    drugs    enalapril    age    drug    data    formulation    patent    young    patients    lena    neonates    insufficient    paediatric    off    pk    safety    children    puma    pd   

 Obiettivo del progetto (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.'

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