NCT05553886RecruitingPhase 3
S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction
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)
Source: ClinicalTrials.gov · Last updated 3 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 21 Sept 2022
- Start date
- 21 Dec 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Shenzhen People's Hospital
- Diseases
- Heart failure
- NCT number
- NCT05553886
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 5
- From 21 Dec 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- He had a history of angioedema 1e.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.