DRUG USE INVESTIGATION OF SELARA(REGISTERED). TABLETS(AN INVESTIGATION FOR CHRONIC HEART FAILURE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,165
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment
研究概览
简要总结
Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice
详细描述
This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. The patients will be observed up until Week 52.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in whom treatment with this drug is for CHF. The indications at approval for this drug are as follows. When using this drug, refer to the latest package insert of this drug.
排除标准
- •Patients who were previously registered for this study. Patients who received eplerenone within the past three months regardless of the reason for use.
研究组 & 干预措施
Eplerenone
Patients with CHF receiving Selara (eplerenone)
干预措施: Eplerenone (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment
时间窗: 52 weeks from the start date
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Selara in a chronic heart failure participant with moderate renal impairment (≥30 mL/min and \<50 mL/min in eCLCr) who received Selara. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Selara was assessed by the physician.
次要结局
- The Overall Mortality Rate(52 weeks from the start date)
- The Number of Deaths (Overall Deaths)(52 weeks from the start date)
- The Cardiovascular-related Mortality Rate(52 weeks from the start date)
- Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants(52 weeks from the start date)
- The Number of Deaths (Cardiovascular Deaths)(52 weeks from the start date)