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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07654140

Enrollment

252

Registered

2026-06-17

Start date

2025-12-09

Completion date

2027-07-31

Last updated

2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncontrolled Hypertension

Keywords

Hypertension, Aldosterone Synthase Inhibitor, Renin, Angiotensin

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.

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.

Interventions

DRUGSAL0140

SAL0140 Tablets

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

CONTACTJun Cai, professor

caijun7879@126.com13810615602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026