NCT07654140 A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Uncontrolled Hypertension
| NCT ID | NCT07654140 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shenzhen Salubris Pharmaceuticals Co., Ltd. |
| Condition | Uncontrolled Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 252 participants in total. It began in 2025-12-09 with a primary completion date of 2027-03-01.
⚠ 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
This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in uncontrolled hypertension.
Eligibility Criteria
Inclusion Criteria: 1. Patients 18-75 years old, male or female. 2. Mean seated systolic blood pressure (msSBP) at screening was ≥140 mmHg and \<180 mmHg. 3. Meet either item A or B at screening: A. Uncontrolled hypertension (uHTN); B. Resistant hypertension (rHTN). 4. Mean seated systolic blood pressure (msSBP) prior to randomization was ≥140 mmHg and \<180 mmHg. 5. Voluntarily participate in this study and sign the informed consent form. 6. Agree to comply with contraception and fertility restrictions of this study. Exclusion Criteria: 1. Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg); malignant hypertension, hypertensive emergency, hypertensive crisis, hypertensive encephalopathy, etc. 2. Compliance with study drug during the run-in period was less than 80% or greater than 120%. 3. Hypertension complicated with the following conditions: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, stroke. 4. Positive results for any of human immunodeficiency virus antibody (HIV), hepatitis C virus antibody (HCV), treponema pallidum antibody (TP); or positive hepatitis B surface antigen (HBsAg) with HBVDNA ≥ 1000 IU/mL. 5. Patients with active malignant tumors. 6. Patients receiving hemodialysis or adhering to strict salt restriction therapy. 7. History of adrenal insufficiency. 8. History of solid organ or bone marrow transplantation. 9. Gastrointestinal diseases or post-gastrointestinal surgery. 10. Known or suspected hypersensitivity to aldosterone synthase inhibitors; known or suspected contraindications or hypersensitivity to background medications. 11. History of drug abuse or alcohol abuse. 12. Blood donation or significant blood loss.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07654140 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Uncontrolled Hypertension. 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 NCT07654140 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07654140 currently recruiting?
Yes, NCT07654140 is actively recruiting participants. Contact the research team at caijun7879@126.com for enrollment information.
Where is the NCT07654140 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07654140 clinical trial?
NCT07654140 is sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd.. The trial plans to enroll 252 participants.