S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

Chronic Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553886
• Other study ID #: Clinical study of S086 tablets
• Status: Recruiting
• Phase: Phase 3
• Start date: December 21, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2022
• Source: Shenzhen People's Hospital
• Contact: junbo he
• Phone: 13434792084
• Email: 527768709[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with chronic heart failure (NYHA grade ?-?) 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.

Related Conditions & MeSH terms

• Chronic Heart Failure With Reduced Ejection Fraction
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
China	Shenzhen People' S Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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