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New treatment option for Chronic Heart Failure With Reduced Ejection Fraction
Official title S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction
ClinicalTrials.gov ID: NCT05553886
What this study is testing
What is 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 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic heart failure with reduced ejection fraction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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...
- Known or suspected allergy to S086, sacubitril valsartan sodium, ARB, ACEI, or enkephin inhibitor (NEPI), and known or suspected contraindications to...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.