S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

Phase 3

Recruiting

• Conditions: Chronic Heart Failure With Reduced Ejection Fraction
• Interventions: Drug: To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug

• Registration Number: NCT05553886
• Lead Sponsor: Shenzhen People's Hospital

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-21
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S086 piece	To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug	Sacubitril alisartan calcium tablets,60mg,120mg,180mg,240mg
Sacubitril valsartan sodium tablets	To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug	Sacubitril valsartan sodium tablets,50mg,100mg

Primary Outcome Measures

Name	Time	Method
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）.	the end of 28th week	Left ventricular ejection fraction (LVEF) changed from baseline at the end of 28th week,Normal result value 50-70%.

Trial Locations

Locations (1)

Shenzhen People' S Hospital; 🇨🇳 Shenzhen, Guangdong, China