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S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

Primary Purpose

Chronic Heart Failure With Reduced Ejection Fraction

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug
Sponsored by
Shenzhen People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shenzhen People' S HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

S086 piece

Sacubitril valsartan sodium tablets

Arm Description

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

Sacubitril valsartan sodium tablets,50mg,100mg

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2022
Last Updated
October 31, 2022
Sponsor
Shenzhen People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05553886
Brief Title
S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure With Reduced Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, positive drug parallel control, multicenter
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S086 piece
Arm Type
Experimental
Arm Description
Sacubitril alisartan calcium tablets,60mg,120mg,180mg,240mg
Arm Title
Sacubitril valsartan sodium tablets
Arm Type
Active Comparator
Arm Description
Sacubitril valsartan sodium tablets,50mg,100mg
Intervention Type
Drug
Intervention Name(s)
To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug
Intervention Description
To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug
Primary Outcome Measure Information:
Title
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).
Description
Left ventricular ejection fraction (LVEF) changed from baseline at the end of 28th week,Normal result value 50-70%.
Time Frame
the end of 28th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
junbo he
Phone
13434792084
Email
527768709@qq.com
Facility Information:
Facility Name
Shenzhen People' S Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Bo He
Phone
13434792084
Email
527768709@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

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