S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

NCT ID: NCT05553886

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-21
• Study Completion Date: 2026-12-31

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)

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

S086 piece

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Sacubitril valsartan sodium tablets

Sacubitril valsartan sodium tablets,50mg,100mg

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shenzhen People' S Hospital

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

junbo he

Role: CONTACT

527768709@qq.com

13434792084

Facility Contacts

Jun Bo He

Role: primary

527768709@qq.com

13434792084

Other Identifiers

Clinical study of S086 tablets

Identifier Type: -

Identifier Source: org_study_id