A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Uncontrolled Hypertension

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Uncontrolled Hypertension

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.

Study Overview

• Status: Recruiting
• Conditions: Uncontrolled Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: SAL0140

Detailed Description

Participants diagnosed with uncontrolled hypertension were randomly assigned to the low-dose group, middle-dose group, high-dose group or placebo group for a double-blind treatment period. Participants subsequently entered a withdrawal period.

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jun Cai, professor; Phone Number: 13810615602; Email: caijun7879@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital Capital Medical University
      • Contact: Jun Cai, professor; Phone Number: 13810615602; Email: caijun7879@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo; Placebo
Experimental: Low-dose group	Drug: SAL0140; SAL0140 Tablets
Experimental: High-dose group	Drug: SAL0140; SAL0140 Tablets
Experimental: Middle-dose group	Drug: SAL0140; SAL0140 Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The baseline change in mean seated systolic blood pressure (msSBP)	Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment	at week 12

Collaborators and Investigators

• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Renin; Angiotensin; Aldosterone Synthase Inhibitor
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: SAL0140A201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No