S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Chronic Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Drug: To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, positive drug parallel control, multicenter
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S086 piece<br>Sacubitril alisartan calcium tablets,60mg,120mg,180mg,240mg | Drug: To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug<br>* To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug<br>|
| Active Comparator: Sacubitril valsartan sodium tablets<br>Sacubitril valsartan sodium tablets,50mg,100mg | Drug: To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug<br>* To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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）. | Left ventricular ejection fraction (LVEF) changed from baseline at the end of 28th week,Normal result value 50-70%. | the end of 28th week |