NCT05553886 S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction
| NCT ID | NCT05553886 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shenzhen People's Hospital |
| Condition | Chronic Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2021-12-21 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 5 participants in total. It began in 2021-12-21 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05553886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05553886 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 5 participants.
Is NCT05553886 currently recruiting?
Yes, NCT05553886 is actively recruiting participants. Contact the research team at 527768709@qq.com for enrollment information.
Where is the NCT05553886 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT05553886 clinical trial?
NCT05553886 is sponsored by Shenzhen People's Hospital. The trial plans to enroll 5 participants.
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