S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug
DrugTo evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug
Treatment groups
5 Participants
are divided into 2 treatment groupsGroup A: S086 pieceExperimental treatment 1 intervention
Group B: Sacubitril valsartan sodium tabletsActive comparator 1 intervention
Trial outcomes
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%.
Time frame
the end of 28th weekSponsors and contacts
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Source ClinicalTrials.gov