Enalapril and Enalaprilat Pharmacokinetics in Children with Heart Failure Due to Dilated Cardiomyopathy and Congestive Heart Failure after Administration of an Orodispersible Enalapril Minitablet (LENA-Studies)

Autor: Stephanie Laeer, Willi Cawello, Bjoern B. Burckhardt, László Ablonczy, Milica Bajcetic, Johannes M. P. J. Breur, Michiel Dalinghaus, Christoph Male, Saskia N. de Wildt, Jörg Breitkreutz, Muhammed Faisal, Anne Keatley-Clarke, Ingrid Klingmann, Florian B. Lagler

Publikováno v: Pharmaceutics, Vol 14, Iss 6, p 1163 (2022)

Angiotensin-converting enzyme inhibitors (ACEI), such as enalapril, are a cornerstone of treatment for pediatric heart failure which is still used off-label. Using a novel age-appropriate formulation of enalapril orodispersible minitablets (ODMTs), p

Externí odkaz: https://doaj.org/article/b89dc3f16c3f4e7d9e7d6a9dfa33561e

Orodispersible minitablets of enalapril for use in children with heart failure (LENA): Rationale and protocol for a multicentre pharmacokinetic bridging study and follow-up safety study

Autor: Milica Bajcetic, Saskia N. de Wildt, Michiel Dalinghaus, Jörg Breitkreutz, Ingrid Klingmann, Florian B. Lagler, Anne Keatley-Clarke, Johannes MPJ. Breur, Christoph Male, Ida Jovanovic, Andras Szatmári, László Ablonczy, Bjoern B. Burckhardt, Willi Cawello, Karl Kleine, Emina Obarcanin, Lucie Spatenkova, Vanessa Swoboda, Marijke van der Meulen, Peter Wagner, Jennifer Walsh, Stephanie Läer

Publikováno v: Contemporary Clinical Trials Communications, Vol 15, Iss , Pp - (2019)

Introduction: Treatment of paediatric heart failure is based on paradigms extensively tested in the adult population assuming similar underlying pathophysiological mechanisms. Angiotensin converting enzyme inhibitors (ACEI) like enalapril are one of

Externí odkaz: https://doaj.org/article/2ac48e9434ae4e17b2e6a84199cdab38

A comprehensive quality control system suitable for academic research: application in a pediatric study

Autor: Nina Makowski, Agnes M Ciplea, Mohsin Ali, Ilja Burdman, Anke Bartel, Bjoern B Burckhardt, Stephanie Läer, Jörg Breitkreutz, Ingrid Klingmann, Florian Lagler, Jan de Hoon, Michel Dalinghaus, Milica Bajcetic, Saskia de Wildt, Anne Keatley Clarke, Johannes Breur, Christoph Male, Laslo Ablonczy, Thomas Mir, Vladislav Vukomanovic, Milan Dukic, Ida Jovanovic, Bjoern Burckhardt, Willi Cawello, Karl Kleine, Angelika Moder, Emina Obarcanin, Peter Wagner, Jennifer Walsh, Anne van Hecken, Lucie Spatenkova, Ali Mohsin, Bojana Božić, Maja Bijelić, Agnes Ciplea, Muhammed Faisal, Samieh Farahani, Martin Feickert, Tanja Gangnus, Milica Lazic, Fabian Süssenbach, Marijke van der Meulen, Saša Popović, Miro Parezanović, Nori Smeets, Vanessa Swoboda, Dragana Bojanin, Stefan Đorđević, Jasminka Dragić, Ann-Kathrin Holle, Bosiljka Jovičić, Jovan Košutić, Gordana Kozomara, Haidara Majid, Jadranka Mitrović, Sanja Ninić, Miro Parezanovic, Vojislav Parezanovic, Andrija Pavlović, Sergej Prijić, Branislava Rebić, Igor Stefanović, Daniel Tordas, Irena Vulićević, Andjelka čeko, Marissa Herborts, Annelies Hennink, Bosiljka Kosanović, Sanja Kostic, Ljiljana Isailović, Jasmina Maksimovic, Badies Manai, Nada Martinović, Gyöngyi Máté, Miloš Perišić, Jelena Reljić, Regina Pirker, Marta Salamomovic, Claudia Schlesner, Jutta Tins, Eva Wissmann

Publikováno v: Bioanalysis, 12, 5, pp. 319-333
Bioanalysis, 12, 319-333

Item does not contain fulltext Aim: Clinical research in pediatrics is progressively initiated by academia. As the reliability of pharmacodynamic measures is closely linked to the quality of bioanalytical data, bioanalytical quality assurance is cruc

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::efa41c6ede99bff4250575c889a10af3
https://hdl.handle.net/2066/220451

Orodispersible minitablets of enalapril for use in children with heart failure (LENA): Rationale and protocol for a multicentre pharmacokinetic bridging study and follow-up safety study

Autor: Lucie Spatenkova, Stephanie Läer, Anne Keatley-Clarke, Jörg Breitkreutz, Saskia N. de Wildt, Michiel Dalinghaus, Marijke van der Meulen, Johannes M.P.J. Breur, Willi Cawello, Jennifer Walsh, Emina Obarcanin, Peter Wagner, Ida Jovanovic, András Szatmári, Milica Bajcetic, Ingrid Klingmann, Christoph Male, Vanessa Swoboda, Bjoern B. Burckhardt, Karl Kleine, Florian B. Lagler, László Ablonczy

Publikováno v: Contemporary Clinical Trials Communications, 15:Unsp 100393. Elsevier Inc.
Contemporary Clinical Trials Communications, 15, pp. 100393
Contemporary Clinical Trials Communications, 15, 100393
Contemporary Clinical Trials Communications, 15. Elsevier Inc.
Contemporary Clinical Trials Communications, Vol 15, Iss, Pp-(2019)
Contemporary Clinical Trials Communications

Introduction: Treatment of paediatric heart failure is based on paradigms extensively tested in the adult population assuming similar underlying pathophysiological mechanisms. Angiotensin converting enzyme inhibitors (ACEI) like enalapril are one of

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1fb7c65d794d1169a7ff85454e6472c4
https://pure.eur.nl/en/publications/ee926aa4-0b8c-4242-8a18-0c14ddf883f5

O-40 NOVEL TAILORED TRAINING CONCEPT TO FACILITATE SUCCESSFUL STUDY CONDUCT AND OPTIMISE RECRUITMENT IN PAEDIATRIC CLINICAL TRIALS.

Autor: Burckhardt, Ciplea, Kleine, Ablonczy, Breur, Dalinghaus, Van der Meulen, Klingmann, Spatenkova, Swoboda, Bajcetic, Keatley-Clarke, Laeer, Lagler

Publikováno v: Archives of Disease in Childhood; Oct2017, Vol. 102 Issue 10, p18-19, 2p