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LENA

Labeling of Enalapril from Neonates up to Adolescents

Few medicines are licensed for children and exist in formulations which are specifically developed for children. The goal of the LENA project is to develop a safe, effective and age-appropriate formulation of the drug Enalapril for children (orally disintegrating mini-tablet, ODMT)

 Enalapril is an angiotensin-converting-enzyme inhibitor that is licensed to treat hypertension and heart failure in adults. Enalapril is licensed for paediatric patients only above 20 kg body weight for treatment of hypertension. It is currently used as an “off-label” drug in children of all ages suffering from hypertension or heart disease for lack of alternatives.

Heart failure in children has different aetiologies and course of disease compared to adults. Therefore, it is essential to study Enalapril in children with various heart conditions. The mini-tablets, which are less than 3mm small and rapidly dissolve in the mouth, allow to reliably administer exact doses of the active ingredient. As part of the development of the Enalapril ODMT, age-appropriate doses, safety and efficacy will be systematically studied in children with heart failure. Upon completion of the LENA studies, Enalapril mini-tablets will be licensed for treatment of heart failure from neonates to adolescents.

Researchers of the Medical University of Vienna

The Medical University of Vienna is project partner under the leadership of Prof. Dr. Christoph Male,  Department of Pediatrics and Adolescent Medicine, Division of Pediatric Cardiology.

Ao. Univ.-Prof. Dr. Christoph Male

Head of Project

Department of Pediatrics and Adolescent Medicine
Division of Pediatric Cardiology

Project coworker:
MSc Dr.in Vanessa Swoboda
DKKS Eva Wissmann
Ing.in Regina Pirker
OA Dr.in Katharina Thom
Ass. Prof. Dr. Andreas Hanslik


Consortium

Head of Project: Prof.in Dr.in Stephanie Läer, Institut für Klinische Pharmazie und Pharmakotherapie, Heinrich-Heine-Universität Düsseldorf, Deutschland.

Project partners: 12


Facts

FTopicHEALTH.2013.4.2-1: Investigator-driven clinical trials for off-patent medicines using innovative, age-appropiate formulations and/or delivery systems
Project Durationab 01/11/2013, 60 Monate Laufzeit
Funding Volume, total6 Mio. €
Funding Volume, Medical University of Vienna117,753.00 €

Projectwebsite

The goal of the LENA project is to develop a safe, effective and age-appropriate formulation of the drug Enalapril for children (orally disintegrating mini-tablet, ODMT).
Learn more on the official projectwebsite

LENA