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Recruiting Phase 3

S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

NCT05553886 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2021-12-21
Last updated
2022-11-03

Condition(s) studied

Chronic Heart Failure With Reduced Ejection Fraction

Investigational drug(s) / intervention(s)

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

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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). — the end of 28th week
    Left ventricular ejection fraction (LVEF) changed from baseline at the end of 28th week,Normal result value 50-70%.

Trial sites (1)

FacilityCityRegionStatus
Shenzhen People' S Hospital Shenzhen Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05553886 on ClinicalTrials.gov ↗ ← All trials in China