S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

NCT05553886 | Recruiting Phase 3

• 1 other identifier: Clinical study of S086 tablets
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

S086 piece

EXPERIMENTAL

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

Sacubitril valsartan sodium tablets

ACTIVE COMPARATOR

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

Interventions

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

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

S086 piece; Sacubitril valsartan sodium tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People' S Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

Central Study Contacts

junbo he

CONTACT

13434792084; 527768709@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, positive drug parallel control, multicenter

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: December 21, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)