Design for the sacubitril/valsartan (LCZ696) compared with enalapril study of pediatric patients with heart failure due to systemic left ventricle systolic dysfunction (PANORAMA-HF study)

Sacubitril/valsartan (LCZ696) is an angiotensin receptor neprilysin inhibitor approved for the treatment of adult heart failure (HF); however, the benefit of sacubitril/valsartan in pediatric HF patients is unknown. This global multi-center study will use an adaptive, seamless two-part design. Part...

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Veröffentlicht in:	The American heart journal 2017-11, Vol.193, p.23-34
Hauptverfasser:	Shaddy, Robert, Canter, Charles, Halnon, Nancy, Kochilas, Lazaros, Rossano, Joseph, Bonnet, Damien, Bush, Christopher, Zhao, Ziqiang, Kantor, Paul, Burch, Michael, Chen, Fabian
Format:	Artikel
Sprache:	eng
Schlagworte:	Adolescent Adults Aminobutyrates - administration & dosage Aminobutyrates - pharmacokinetics Angiotensin Angiotensin II Type 1 Receptor Blockers - administration & dosage Angiotensin II Type 1 Receptor Blockers - pharmacokinetics Angiotensin-Converting Enzyme Inhibitors - administration & dosage Angiotensin-Converting Enzyme Inhibitors - pharmacokinetics Cardiomyopathy Cardiovascular disease Child Child, Preschool Clinical trials Congenital diseases Design Dose-Response Relationship, Drug Drug Combinations Drug dosages Drug therapy Drug Therapy, Combination Enalapril - administration & dosage Enalapril - pharmacokinetics Enzymes FDA approval Female Follow-Up Studies Heart Heart diseases Heart failure Heart Failure - drug therapy Heart Failure - etiology Heart Failure - metabolism Heart transplantation Humans Infant Infant, Newborn Male Mortality Myocardial Ischemia - complications Myocardial Ischemia - diagnosis Myocardial Ischemia - physiopathology Neprilysin Patients Pediatrics Pharmacodynamics Pharmacokinetics Pharmacology Prospective Studies Quality of life Systole Tetrazoles - administration & dosage Tetrazoles - pharmacokinetics Time Factors Transplants & implants Treatment Outcome Valsartan - administration & dosage Valsartan - pharmacokinetics Ventricle Ventricular Dysfunction, Left - complications Ventricular Dysfunction, Left - diagnosis Ventricular Dysfunction, Left - physiopathology Ventricular Function, Left - physiology
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Zusammenfassung:	Sacubitril/valsartan (LCZ696) is an angiotensin receptor neprilysin inhibitor approved for the treatment of adult heart failure (HF); however, the benefit of sacubitril/valsartan in pediatric HF patients is unknown. This global multi-center study will use an adaptive, seamless two-part design. Part 1 will assess the pharmacokinetics/pharmacodynamics of single ascending doses of sacubitril/valsartan in pediatric (1 month to
ISSN:	0002-8703 1097-6744
DOI:	10.1016/j.ahj.2017.07.006