A Phase II Clinical Trial of Efficacy and Safety of SAL01... | NCT07654140

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

NCT07654140

Sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Status

Recruiting

Last Update Posted

Jun 17, 2026Actual

Enrollment

252Estimated

Phase

Phase 2

Conditions

Uncontrolled Hypertension

Interventions

SAL0140
SAL0140
SAL0140
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2025Actual

Primary Completion Date

Mar 1, 2027Estimated

Completion Date

Jul 31, 2027Estimated

First Submitted Date

Jun 12, 2026

First Submission Date that Met QC Criteria

Jun 12, 2026

First Posted Date

Jun 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2026

Last Update Posted Date

Jun 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

252Estimated

Label	Type	Intervention Names
Low-dose group	Experimental	Drug: SAL0140
Middle-dose group	Experimental	Drug: SAL0140
High-dose group	Experimental	Drug: SAL0140
Placebo group	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
SAL0140	Drug	SAL0140 Tablets	Low-dose group
SAL0140

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases