Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure, CLCZ696F1401)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 29
- 主要终点
- Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration
研究概览
简要总结
This is multicenter, single-arm, non-interventional, centrally enrolled specified drug-use survey to investigate the safety of Entresto Tablets or Entresto Granules for Pediatric in pediatric patients with chronic heart failure in actual clinical settings for up to 52 weeks after administration.
详细描述
This specified drug-use survey is conducted to collect information on the safety specifications of Entresto in pediatric patients with chronic heart failure in Japan in actual clinical settings, and to investigate the occurrence of events related to the safety specifications, the risk factors associated with these events, and the status of Entresto administration including the accidental administration of capsule-shaped container (Granules for Pediatric). The subjects of this study are pediatric patients and a long-term observation of 1 year (52 weeks) has been set.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent by a legally acceptable representative must be obtained before the start of treatment with Entresto.
- •Patients who received Entresto for the first time under the indication of chronic heart failure
- •Pediatric patients aged 1 to < 18 years old at the start of treatment with Entresto
排除标准
- •Patients who have received drugs containing the same ingredient as Entresto (including investigational products and drugs for post-marketing clinical study)
- •Patients for whom Entresto is contraindicated according to the package insert
- •Patients with a history of hypersensitivity to any ingredients of Entresto
- •Patients currently under treatment with angiotensin-converting enzyme inhibitors or within 36 hours of discontinuation of treatment with angiotensin-converting enzyme inhibitors (alacepril, imidapril hydrochloride, enalapril maleate, captopril, quinapril hydrochloride, cilazapril hydrate, temocapril hydrochloride, delapril hydrochloride, trandolapril, benazepril hydrochloride, perindopril erbumine, lisinopril hydrate).
- •Patients with a history of angioedema (including angioedema due to angiotensin II receptor blockers or angiotensin-converting enzyme inhibitors, hereditary angioedema, acquired angioedema, and idiopathic angioedema etc.)
- •Patients with diabetes mellitus under treatment with aliskiren fumarate (excluding patients with markedly poorly controlled blood pressure despite other antihypertensive therapies)
- •Patients with severe hepatic impairment (Child-Pugh class C)
- •Pregnant women or women who may be pregnant
结局指标
主要结局
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration
时间窗: one year
To confirm the occurrence status up to 52 weeks of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration as safety specifications of Entresto administration in pediatric patients with chronic heart failure in actual clinical settings.
次要结局
- Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration by the risk factors(one year)
- Occurrence of the accidental administration of the capsule-shaped container (Granules for Pediatric)(one year)
- Occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions(one year)
- Administration status of Entresto during the observation period(one year)