EUCTR2015-004207-22-CZ进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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 = 45% or fractional
- •shortening =22.5%
- •(assessed by most recent echocardiography, MRI, MUGA or left
- •ventricular angiogram within 1 month before patient begins Part 2).
- •[Note: The study will target enrollment of approximately 80% patients
- •systemic left ventricular ejection fraction (EF) = 40% or fractional
- •shortening =20% for Part 2 only].
- •- Biventricular physiology with systemic left ventricle
- •- 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 a daily dose equivalent of at least enalapril 0.2 mg/kg prior to the
- •LCZ696 3.1 mg/kg single dose assessment.
- •For Part 1 PK/PD, patients in Group 3 must be currently treated with a
- •daily dose equivalent of at least enalapril 0.1 mg/kg prior to the LCZ696
- •1.6 mg/kg single dose assessment
- •Sub-study entry criteria:
- •The patient is assigned at randomization in Part 2 of the main study
- •CLCZ696B2319 to one of the following formulations:
- •LCZ696/ placebo liquid
- •CZ696/ placebo granules
- •- Participant and/or participant's parent/caregiver capable of
- •understanding the
- •assessment procedures and participant obligations.
- •- Must not have any impairment in swallowing either solids or liquids as
- •a consequence of acute or chronic illness and /or the inability to
- •participate in the
- •palatability/acceptability assessment due to a condition that includes
- •loss or alteration of taste.
- •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
排除标准
- •- 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
- •- For part 2 only, 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
- •- For part 2 only, 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
- •Women of child-bearing potential, defined as all women physiologically
- •capable of becoming pregnant, unless they are using highly effective
- •methods of contraception during dosing of investigational drug
- •- Patient breastfed by a mother taking ACEI
- •Other protocol defined inclusion/exclusion criteria may apply.
研究者
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