Special Drug Use Surveillance for Entresto Tablets (Chronic Heart Failure, CLCZ696B1401)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 688
- 试验地点
- 1
- 主要终点
- To evaluate the safety of Entresto in chronic heart failure patients
研究概览
简要总结
This is a single arm, multicenter, observational study in Japanese chronic heart failure patients.
详细描述
This study is a special drug use surveillance to evaluate the safety and efficacy of Entresto Tablets (hereafter called Entresto) clinically administered in Japanese patients for the newly approved indication of "chronic heart failure" and to be conducted as one of the RMP-specified additional pharmacovigilance activities.
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
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must provide written consent to cooperate in this study before the start of Entresto
- •Patients using Entresto for the first time for the following indication Indication: chronic heart failure patients on standard of care for chronic heart failure
排除标准
- •Patients with a history of treatment with a drug containing the same ingredient (investigational drug or post-marketing clinical study drug) as Entresto
- •The following patients for whom Entresto is contraindicated in the package insert Patients with a history of hypersensitivity to any of the Entresto ingredients Patients with a history of angioedema (angiotensin II receptor blockers or angiotensin converting enzyme inhibitors-induced angioedema, hereditary angioedema, acquired angioedema, idiopathic angioedema etc.) Diabetic patients on aliskiren fumarate Patients with severe hepatic impairment (Child-Pugh class C) Pregnant or possibly pregnant women
研究组 & 干预措施
Entresto
Patients administered Entresto by prescription
干预措施: Entresto (Drug)
结局指标
主要结局
To evaluate the safety of Entresto in chronic heart failure patients
时间窗: Up to 52 weeks
EAIR of hypotension, hyperkalemia, renal impairment and dehydration will be collected. EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients
次要结局
- To evaluate the impact of risk factors(Up to 52 weeks)
- To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs(Up to 52 weeks)
- EAIR for each of the clinical events(Up to 52 weeks)
- Kaplan-Meier curve for each of the clinical events(Up to 52 weeks)
- Total frequency of hospitalization due to heart failure(Up to 52 weeks)
- To investigate data on the administration of Entresto in clinical use(Up to 52 weeks)