NCT01345656已完成2 期
A Randomized, Double-blind, Multi-center Study to Assess Safety and Tolerability of Different Oral Doses of BAY94-8862 in Subjects With Stable Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease Versus Placebo (Part A) or Versus Placebo and Spironolactone (Part B)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 457
- 主要终点
- Change of serum potassium
研究概览
简要总结
A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy
- •Clinical diagnosis of CHF (chronic heart failure), either ischemic or non-ischemic, NYHA (New York Heart Association) class II - III, treated with evidenced-based therapy for CHF, e.g. beta-blockers and ACE (angiotensin-converting enzyme) inhibitors or ARB (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated
- •Known kidney damage for >/= 3 months, as defined by structural or functional abnormalities of the kidney, and
- •Part A: 60 mL/min/1.73 m*2 </= eGFR (estimated Glomerular Filtration Rate) < 90 mL/min/1.73 m*2 (MDRD, Modification of Diet in Renal Disease) at the screening visit
- •Part B: 30 mL/min/1.73 m*2 </= eGFR <= 60 mL/min/1.73 m*2 (MDRD) at the screening visit
- •Serum potassium </= 4.8 mmol/L at the screening visit
- •Systolic blood pressure >/= 90 mmHg without signs or symptoms of hypotension at the screening visit
排除标准
- •Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only)
- •Subjects with anuria, acute renal failure, or Addison's disease
- •Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization
- •Valvular heart disease requiring surgical intervention during the course of the study
- •History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY94-8862 (Drug)
Arm 2
Experimental
干预措施: BAY94-8862 (Drug)
Arm 3
Experimental
干预措施: BAY94-8862 (Drug)
Arm 4
Experimental
干预措施: BAY94-8862 (Drug)
Arm 5
Placebo Comparator
干预措施: Placebo (Drug)
Arm 6
Active Comparator
干预措施: Spironolactone (Drug)
结局指标
主要结局
Change of serum potassium
时间窗: 4 weeks
次要结局
- Change in serum magnesium(Day 8, Day 15, Day 22, Day 29)
- Change in blood pressure(Day 8, Day 15, Day 22, Day 29)
- Change in heart rate(Day 8, Day 15, Day 22, Day 29)
研究者
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