Clinical Trials in China / NCT07654140
Recruiting
Phase 2
A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Uncontrolled Hypertension
NCT07654140 · tracked via the Priya Life Science China tracker
Condition(s) studied
Uncontrolled Hypertension
Investigational drug(s) / intervention(s)
SAL0140: SAL0140 Tablets
SAL0140: SAL0140 Tablets
SAL0140: SAL0140 Tablets
Placebo: Placebo
Study 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
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.
Primary outcome measure(s)
- The baseline change in mean seated systolic blood pressure (msSBP) — at week 12
Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Anzhen Hospital Capital Medical University | Beijing | Beijing Municipality | Recruiting |
More Shenzhen Salubris Pharmaceuticals Co., Ltd. trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07654140 on ClinicalTrials.gov ↗ ← All trials in China