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

NCT07654140 | Recruiting Phase 2

• 1 other identifier: SAL0140A201
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncontrolled Hypertension

Keywords

Hypertension; Aldosterone Synthase Inhibitor; Renin; Angiotensin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Low-dose group

EXPERIMENTAL

Drug: SAL0140

Middle-dose group

EXPERIMENTAL

Drug: SAL0140

High-dose group

EXPERIMENTAL

Drug: SAL0140

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SAL0140 DRUG

SAL0140 Tablets

Low-dose group

Placebo DRUG

Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-75 years old, male or female.
• Mean seated systolic blood pressure (msSBP) at screening was ≥140 mmHg and \<180 mmHg.
• Meet either item A or B at screening: A. Uncontrolled hypertension (uHTN); B. Resistant hypertension (rHTN).
• Mean seated systolic blood pressure (msSBP) prior to randomization was ≥140 mmHg and \<180 mmHg.
• Voluntarily participate in this study and sign the informed consent form.
• Agree to comply with contraception and fertility restrictions of this study.

You may not qualify if:

• Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg); malignant hypertension, hypertensive emergency, hypertensive crisis, hypertensive encephalopathy, etc.
• Compliance with study drug during the run-in period was less than 80% or greater than 120%.
• Hypertension complicated with the following conditions: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, stroke.
• 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.
• Patients with active malignant tumors.
• Patients receiving hemodialysis or adhering to strict salt restriction therapy.
• History of adrenal insufficiency.
• History of solid organ or bone marrow transplantation.
• Gastrointestinal diseases or post-gastrointestinal surgery.
• Known or suspected hypersensitivity to aldosterone synthase inhibitors; known or suspected contraindications or hypersensitivity to background medications.
• History of drug abuse or alcohol abuse.
• Blood donation or significant blood loss.

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Beijing Anzhen Hospital Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jun Cai, professor

CONTACT

13810615602; caijun7879@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)