NCT01115855已完成3 期
The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Japanese Subjects With Chronic Heart Failure
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.54 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 221
- 试验地点
- 54
- 主要终点
- Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)
研究概览
简要总结
A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo.
详细描述
The aim of this study was to show consistency with the EMPHASIS-HF trial (NCT00232180), which was defined as a HR of the primary endpoint of below 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese chronic systolic heart failure patients with LVEF =<30% by echocardiography and NYHA II or more
- •Patients who receive standard therapy (Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blocker or diuretic)
排除标准
- •Patients with a myocardial infarction, stroke, cardiac surgery or percutaneous coronary intervention within 30 days prior to randomization.
- •Patients with serum potassium >5.0 mmol/L or eGFR <30 ml/min/1.73 m2.
研究组 & 干预措施
Eplerenone arm
Experimental
Add on standard heart failure therapy
干预措施: Eplerenone (Drug)
Placebo arm
Placebo Comparator
Add on standard heart failure therapy
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)
时间窗: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
次要结局
- Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With With First Occurrence of All-Cause Mortality(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With With First Occurrence of Cardiovascular Mortality(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With First Occurrence of All-cause Hospitalization(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF)(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI)(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Number of Participants With First Occurrence of Hospitalization for Hyperkalemia(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Change From Baseline in Plasma Concentration of Brain Natriuretic Peptide at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit(Baseline, Months 5,9,13,17,21,25,29,33,37,42,48, Final Visit (up to Month 48))
- Change From Baseline in Plasma Concentration of Serum N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit(Baseline, Months 5, 9, 13, 17, 21 ,25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48))
- Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit(Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48))
- Change From Baseline in Urine Albumin-to-Creatinine Ratio at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit(Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48))
- Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit(Baseline, Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48))
- Number of Participants With First Occurrence of New Onset Diabetes Mellitus(Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days))
- Change From Baseline in Specific Activity Scale (SAS) Score at Week 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit(Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48))
研究者
研究点 (54)
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