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 from1 month to < 18 years of age with heart failure due to systemic left ventricle systolic dysfunction

ovartis Farmacéutica, S.A.0 个研究点目标入组 360 人开始时间: 2016年11月15日最近更新: 2021年11月22日

试验速览

暂无简介。

•- Chronic heart failure resulting from left ventricular systolic dysfunction, and receiving chronic HF therapy (if not newly diagnosed)
•- 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 = 40% or fractional shortening =20%
•- For Part 1 PK/PD, patients must be treated with an ACEI (Angiotensin converting enzyme inhibitor) or ARB (Angiotensin receptor blockers) prior to screening. For Part 1 PK/PD, 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 single dose assessment.
•- Biventricular physiology with systemic left ventricle
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 360
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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 at Visit 1 or at Visit 301
•- History of angioedema
•- Allergy or hypersensitivity to ACEI / ARB
•Other protocol defined inclusion/exclusion criteria may apply.

发起方

ovartis Farmacéutica, S.A.