EUCTR2011-000301-45-DK进行中（未招募）不适用
A randomized, double-blind, multi-center study to assess safety and tolerability of different oral doses ofBAY 94-8862 in subjects with stable chronic heart failure with left ventricular systolic dysfunction andmild (Part A) or moderate (Part B) chronic kidney disease versus placebo (Part A) or versus placebo andspironolactone (Part B) - ARTS study
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 425
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 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
- •2. 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
- •3. Known kidney damage for >/= 3 months, as defined by structural or functional abnormalities of the kidney, and
- •-- Part A: 60 mL/min/1.73 m2 -- Part B: 30 mL/min/1.73 m2 4. Serum potassium 5. Systolic blood pressure >/= 90 mmHg without signs or symptoms of hypotension at the screening visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 340
排除标准
- •1. Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only)
- •2. Subjects with anuria, acute renal failure, or Addison’s disease
- •3. Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization
- •4. Valvular heart disease requiring surgical intervention during the course of the study
- •5. History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment
研究者
相似试验
进行中（未招募）
1 期
A study to assess the efficacy and safety of ceftobiprole medocaril compared to daptomycin in the treatment of Staphylococcus aureus bacteremia, including infective endocarditisComplicated staphylococcus aureus bacteremia (cSAB)MedDRA version: 20.1Level: LLTClassification code 10058887Term: Staphylococcus aureus bacteremiaSystem Organ Class: 100000004862EUCTR2017-001699-43-ESBasilea Pharmaceutica International Ltd390
进行中（未招募）
不适用
BAY94-8862 dose finding trial in subjects with chronic heart failure and mild (Part A) or moderate (Part B) chronic kidney diseaseEUCTR2011-000301-45-SEBayer HealthCare AG425
进行中（未招募）
1 期
A study to assess the efficacy and safety of ceftobiprole medocaril compared to daptomycin in the treatment of Staphylococcus aureus bacteremia, including infective endocarditisComplicated staphylococcus aureus bacteremia (cSAB)MedDRA version: 20.1Level: LLTClassification code 10058887Term: Staphylococcus aureus bacteremiaSystem Organ Class: 100000004862EUCTR2017-001699-43-ITBasilea Pharmaceutica International Ltd390
进行中（未招募）
不适用
BAY94-8862 dose finding trial in subjects with chronic heart failure and mild (Part A) or moderate (Part B) chronic kidney diseaseEUCTR2011-000301-45-FIBayer HealthCare AG425
进行中（未招募）
1 期
A study to assess the efficacy and safety of ceftobiprole medocaril compared to daptomycin in the treatment of Staphylococcus aureus bacteremia, including infective endocarditisComplicated staphylococcus aureus bacteremia (cSAB)MedDRA version: 21.1Level: LLTClassification code 10058887Term: Staphylococcus aureus bacteremiaSystem Organ Class: 100000004862EUCTR2017-001699-43-GRBasilea Pharmaceutica International Ltd390