Tests S086 tablets against a standard drug in heart failure with reduced ejection fraction
Compares S086 tablets with a standard drug in adults with heart failure.
Plain-language title generated from the registry record
Registry title: S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 3
Where in China
- Shenzhen People's HospitalShenzhen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen People's Hospital
- Trial code
- NCT05553886
- Record updated
- 3 November 2022
- Original description
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)Read full original descriptionShow less
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)
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)
Inclusion: 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: 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; A previous history of intolerance to the recommended target dose of ACEI or ARB 1d; Acute coronary syndrome occurred within 6 weeks before visit 1 1f; He had a history of angioedema 1e; Previous continuous administration of sacubitril valsartan sodium 150mg bid or more for more than 3 months 1a; 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.