S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

Southern University of Science and Technology

Status and phase: Enrolling; Phase 3

Conditions: Chronic Heart Failure With Reduced Ejection Fraction

Treatments: Drug: To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug

Study type: Interventional

Funder types: Other

Identifiers

NCT05553886

Clinical study of S086 tablets

Details and patient eligibility

About

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)

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with chronic heart failure (NYHA grade ⅱ-ⅳ) with reduced ejection fraction (LVEF≤40%) and elevated BNP were diagnosed 1a.
2. 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.
3. Volunteer to participate in the trial and sign an informed consent form 1c.

Exclusion criteria

1. Previous continuous administration of sacubitril valsartan sodium 150mg bid or more for more than 3 months 1a.
2. 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.
3. 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.
4. A previous history of intolerance to the recommended target dose of ACEI or ARB 1d.
5. He had a history of angioedema 1e.
6. Acute coronary syndrome occurred within 6 weeks before visit 1 1f.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups

S086 piece

Experimental group

Description:

Sacubitril alisartan calcium tablets,60mg,120mg,180mg,240mg

Treatment:

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

Sacubitril valsartan sodium tablets

Active Comparator group

Description:

Sacubitril valsartan sodium tablets,50mg,100mg

Treatment:

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