S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

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)

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)

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Recruiting
      • Shenzhen People' S Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S086 piece; 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; To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug
Active Comparator: Sacubitril valsartan sodium tablets; 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; To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Clinical study of S086 tablets

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No