Uncontrolled HypertensionPhase 2NCT07654140
A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Uncontrolled Hypertension
A Phase 2 study testing SAL0140 in people with Uncontrolled Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- SAL0140
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2025to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital Capital Medical University
Beijing, Beijing Municipality, 100029
Jun Cai, professor, 13810615602, caijun7879@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Uncontrolled Hypertension
- Being tested
- SAL0140, Placebo
- Keywords
- Hypertension, Aldosterone Synthase Inhibitor, Renin, Angiotensin
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAL0140Drug
SAL0140 Tablets
SAL0140Drug
SAL0140 Tablets
SAL0140Drug
SAL0140 Tablets
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | Not described Receives: Drug: SAL0140 |
| Middle-dose group | Experimental | Not described Receives: Drug: SAL0140 |
| High-dose group | Experimental | Not described Receives: Drug: SAL0140 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start9 Dec 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654140
- Sponsor's protocol ID
- SAL0140A201
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07654140
- Acronym / sponsor ID
- SAL0140A201
- Conditions
- Uncontrolled Hypertension
- Keywords
- Hypertension, Aldosterone Synthase Inhibitor, Renin, Angiotensin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: SAL0140 |
| Middle-dose group | Experimental | Drug: SAL0140 |
| High-dose group | Experimental | Drug: SAL0140 |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAL0140SAL0140 Tablets | Drug | Low-dose group |
| SAL0140SAL0140 Tablets | Drug | Middle-dose group |
| SAL0140SAL0140 Tablets | Drug | High-dose group |
| PlaceboPlacebo | Drug | Placebo group |
Primary outcome
The baseline change in mean seated systolic blood pressure (msSBP)
Time frame: at week 12
Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Uncontrolled Hypertension
Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Hypertension
Not yet recruitingPhase 2
A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
Uncontrolled Hypertension, Resistant Hypertension
RecruitingPhase 2
A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
Uncontrolled Hypertension
Recruiting
Effectiveness and Cost-Effectiveness of a Digital Care Pathway and Asynchronous Communication for Patients With Hypertension
Hypertension
RecruitingPhase 2/3
A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
Uncontrolled or Resistant Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAL0140 in people with Uncontrolled Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Cai, professor (13810615602, caijun7879@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The baseline change in mean seated systolic blood pressure (msSBP) (time frame: at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.