Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction

CompletadoFase 3ClinicalTrials.gov

ID: NCT02678312Tipo: INTERVENTIONALInicio: 3 de nov de 2016Fin estimado: 3 de ene de 2022

Traducción no disponible, mostrando original

Resumen

This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.

Descripción detallada

Elegibilidad

Edad mínima: 1 MonthEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Chronic heart failure (CHF) resulting from left ventricular systolic dysfunction, and receiving chronic HF therapy (if not newly diagnosed)
New York Heart Association (NYHA) classification II-IV (older children: 6 to \<18 years old) or Ross CHF classification II-IV (younger children: \< 6 years old)
Systemic left ventricular ejection fraction ≤ 45% or fractional shortening ≤22.5%
For Part 1 study: Patients must be treated with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB) prior to screening. Patients in Group 1 and 2 must be currently treated with the dose equivalent of at least enalapril 0.2 mg/kg prior to the LCZ696 3.1 mg/kg administration. Group 3 patients will participate in LCZ696 0.8 mg/kg and not LCZ696 3.1 mg/kg.
Biventricular physiology with systemic left ventricle

Criterios de exclusión

Patient with single ventricle or systemic right ventricle
Patients listed for heart transplantation (as United Network for Organ Sharing status 1A) or hospitalized waiting for transplant (while on inotropes or with ventricular assist device)
Sustained or symptomatic dysrhythmias uncontrolled with drug or device therapy
Patients that have had cardiovascular surgery or percutaneous intervention to palliate or correct congenital cardiovascular malformations within 3 months of the screening visit. Patients anticipated to undergo corrective heart surgery during the 12 months after entry into Part 2
Patients with unoperated obstructive or severe regurgitant valvular (aortic, pulmonary, or tricuspid) disease, or significant systemic ventricular outflow obstruction or aortic arch obstruction
Patients with restrictive or hypertrophic cardiomyopathy
Active myocarditis
Renal vascular hypertension (including renal artery stenosis)
Moderate-to severe obstructive pulmonary disease
Serum potassium \> 5.3 mmol/L
History of angioedema
Allergy or hypersensitivity to ACEI / ARB

Intervenciones

drug

LCZ696

LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules)

drug

Enalapril

Enalapril tablets: 2.5 mg, 5 mg, 10 mg dosage strengths

drug

Placebo of LCZ696

drug

Placebo of Enalapril

drug

LCZ696

LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules), tablets: 50 mg, 100 mg, 200 mg dosage strengths

Ubicaciones

Novartis Investigative Site

Ramos Mejía, Buenos Aires, Argentina

Novartis Investigative Site

Salta, Salta Province, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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