S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen People's Hospital

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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