A Randomized, Double-blind, Positive-drug Parallel Controlled, Multicenter Phase III Trial of the Efficacy and Safety of S086 Tablets in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Sacubitril valsartan sodium tablets (trade name: Nohintal) were used as a control to study the efficacy of S086 tablets in the treatment of Chronic heart failure with reduced ejection fraction（HFrEF）.
研究概览
简要总结
A randomized, double-blind, positive-drug parallel controlled, multicenter phase III trial of the efficacy and safety of S086 tablets in patients with chronic heart failure with reduced ejection fraction (HFrEF)
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
- •Patients with chronic heart failure (NYHA grade ⅱ-ⅳ) with reduced ejection fraction (LVEF≤40%) and elevated BNP were diagnosed 1a.
- •Patients received a stable dose of the underlying treatment for heart failure, defined as no change in dose for at least 4 weeks before screening 1b.
- •Volunteer to participate in the trial and sign an informed consent form 1c.
排除标准
- •Previous continuous administration of sacubitril valsartan sodium 150mg bid or more for more than 3 months 1a.
- •Use of other study drugs or use of any study medical device within 1 day of the visit or within 30 days prior to the visit or within 5 half-lives of the drug, whichever is longer 1b.
- •Known or suspected allergy to S086, sacubitril valsartan sodium, ARB, ACEI, or enkephin inhibitor (NEPI), and known or suspected contraindications to sacubitril valsartan sodium 1c.
- •A previous history of intolerance to the recommended target dose of ACEI or ARB 1d.
- •He had a history of angioedema 1e.
- •Acute coronary syndrome occurred within 6 weeks before visit 1 1f.
研究组 & 干预措施
S086 piece
Sacubitril alisartan calcium tablets,60mg,120mg,180mg,240mg
干预措施: To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug (Drug)
Sacubitril valsartan sodium tablets
Sacubitril valsartan sodium tablets,50mg,100mg
干预措施: To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug (Drug)
结局指标
主要结局
Sacubitril valsartan sodium tablets (trade name: Nohintal) were used as a control to study the efficacy of S086 tablets in the treatment of Chronic heart failure with reduced ejection fraction（HFrEF）.
时间窗: the end of 28th week
Left ventricular ejection fraction (LVEF) changed from baseline at the end of 28th week,Normal result value 50-70%.
次要结局
未报告次要终点