Uncontrolled HypertensionPhase 3NCT07790120
A Study to Evaluate the Efficacy and Safety in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
A Phase 3 study testing SAL0120 in people with Uncontrolled Hypertension and Resistant Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is a Phase II, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, and effect of low, middle and high dose of SAL0120 versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 256 participants aged ≥ 18… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Uncontrolled Hypertension, Resistant Hypertension
- What is being tested?
- SAL0120
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2024to 2 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Age 18 to 75 years (inclusive), male or female
- Diagnosis of essential hypertension
- Mean seated systolic blood pressure (msSBP) ≥ 140 mmHg and < 180 mmHg at screening
- At screening, subjects must meet one of the following criteria (A or B):
- A: Uncontrolled hypertension (uHTN)
- Receiving a stable regimen of the following antihypertensive drugs at the maximum tolerated dose for at least 4 weeks prior to screening (as combination therapy or single-pill combination), as judged by the investigator, and in whom an additional antihypertensive agent is considered at screening:
Show all 12Show fewer
- ACEI/ARB/ARNI + diuretic CCB + diuretic Beta-blockers used for the treatment of other conditions (e.g., migraine, heart failure, coronary artery disease) are not considered antihypertensive agents.
- B: Resistant hypertension (rHTN):
- Receiving a stable regimen of the following antihypertensive drugs at the maximum tolerated dose for at least 4 weeks prior to screening (as combination therapy or single-pill combination), as judged by the investigator, and in whom an additional antihypertensive agent is considered at screening:
- ACEI/ARB/ARNI + CCB + diuretic ACEI/ARB/ARNI + CCB + diuretic + beta-blocker/aldosterone receptor antagonist/centrally acting agent/alpha-blocker Beta-blockers used for the treatment of other conditions (e.g., migraine, heart failure, coronary artery disease) are not considered antihypertensive agents.
- msSBP ≥ 140 mmHg and < 180 mmHg at the end of the single-blind run-in period or prior to randomization
- All male subjects and female subjects of childbearing potential agree to use highly effective contraceptive methods from the date of signing the ICF until 1 month after discontinuation of study treatment.
Who cannot join
- Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg); malignant hypertension, hypertensive emergency, hypertensive crisis, or hypertensive encephalopathy;
- History or diagnostic evidence of secondary hypertension, including but not limited to: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary aldosteronism, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension;
- Medication compliance < 80% or > 120% during the single-blind run-in period;
- Clinically significant laboratory abnormalities, including but not limited to: serum ALT and/or AST > 2.5 × upper limit of normal (ULN); total bilirubin > 2 × ULN; eGFR < 30 mL/min/1.73 m² estimated by the simplified Modification of Diet in Renal Disease (MDRD) equation; any clinically significant laboratory abnormality that, in the investigator's opinion, may interfere with the evaluation of efficacy and/or safety data of this study; type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c > 8.0%);
- Severe obesity with body mass index (BMI) > 40 kg/m² (BMI = weight (kg) / height² (m²));
- Hemoglobin < 100 g/L, or blood transfusion for anemia within 3 months prior to screening;
- Subjects with a documented history of anxiety or depression;
- Female subjects who are pregnant, breastfeeding, or have a positive pregnancy test
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of SAL0120 Tablets in Patients Uncontrolled Hypertension on Two or More Medications
This is a Phase II, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, and effect of low, middle and high dose of SAL0120 versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 256 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).
- Conditions
- Uncontrolled Hypertension, Resistant Hypertension
- Being tested
- SAL0120, Placebo
- Keywords
- Uncontrolled Hypertension, Resistant Hypertension, SAL0120
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAL0120Drug
SAL0120 Administered orally, once daily (QD):
Low dose, Middle dose, High dose
PlaceboDrug
Placebo Administered orally, once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| SAL0120 low dose | Experimental | SAL0120：Administered orally, once daily (QD) Receives: Drug: SAL0120 |
| Placebo | Placebo comparator | Placebo：Administered orally, once daily (QD) Receives: Drug: Placebo |
| SAL0120 Middle dose | Experimental | SAL0120: Administered orally, once daily (QD) Receives: Drug: SAL0120 |
| SAL0120 high dose | Experimental | SAL0120: Administered orally, once daily (QD) Receives: Drug: SAL0120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Seated Systolic Blood Pressure for low, middle and high dose of SAL0120
To assess the effect of low, middle and high dose of SAL0120 versus placebo on seated systolic blood pressure at Week 12
Measured: at Week 12
Change From Baseline in Seated Systolic Blood Pressure for low, middle and high dose of SAL0120
To assess the effect of low, middle and high dose of SAL0120 versus placebo on seated systolic blood pressure at Week 4, 8
Measured: At Week 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start29 Oct 2024
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
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
- NCT07790120
- Sponsor's protocol ID
- SAL0120B201
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of SAL0120 Tablets in Patients Uncontrolled Hypertension on Two or More Medications
- ClinicalTrials.gov ID
- NCT07790120
- Acronym / sponsor ID
- SAL0120B201
- Conditions
- Uncontrolled Hypertension, Resistant Hypertension
- Keywords
- Uncontrolled Hypertension, Resistant Hypertension, SAL0120
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 27 Aug 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 Phase II, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, and effect of low, middle and high dose of SAL0120 versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 256 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).
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 |
|---|---|---|
| SAL0120 low dose | Experimental | Drug: SAL0120SAL0120：Administered orally, once daily (QD) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo：Administered orally, once daily (QD) |
| SAL0120 Middle dose | Experimental | Drug: SAL0120SAL0120: Administered orally, once daily (QD) |
| SAL0120 high dose | Experimental | Drug: SAL0120SAL0120: Administered orally, once daily (QD) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 to 75 years (inclusive), male or female
- Diagnosis of essential hypertension
- Mean seated systolic blood pressure (msSBP) ≥ 140 mmHg and < 180 mmHg at screening
- At screening, subjects must meet one of the following criteria (A or B):
- A: Uncontrolled hypertension (uHTN)
Key exclusion criteria (8 listed)
- Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg); malignant hypertension, hypertensive emergency, hypertensive crisis, or hypertensive encephalopathy;
- History or diagnostic evidence of secondary hypertension, including but not limited to: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary aldosteronism, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension;
- Medication compliance < 80% or > 120% during the single-blind run-in period;
- Clinically significant laboratory abnormalities, including but not limited to: serum ALT and/or AST > 2.5 × upper limit of normal (ULN); total bilirubin > 2 × ULN; eGFR < 30 mL/min/1.73 m² estimated by the simplified Modification of Diet in Renal Disease (MDRD) equation; any clinically significant laboratory abnormality that, in the investigator's opinion, may interfere with the evaluation of efficacy and/or safety data of this study; type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c > 8.0%);
- Severe obesity with body mass index (BMI) > 40 kg/m² (BMI = weight (kg) / height² (m²));
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 |
|---|---|---|
| SAL0120SAL0120 Administered orally, once daily (QD): Low dose, Middle dose, High dose | Drug | SAL0120 Middle dose, SAL0120 high dose, SAL0120 low dose |
| PlaceboPlacebo Administered orally, once daily (QD) | Drug | Placebo |
Primary outcome
Change From Baseline in Seated Systolic Blood Pressure for low, middle and high dose of SAL0120
Time frame: at Week 12
To assess the effect of low, middle and high dose of SAL0120 versus placebo on seated systolic blood pressure at Week 12
Change From Baseline in Seated Systolic Blood Pressure for low, middle and high dose of SAL0120
Time frame: At Week 4, 8
To assess the effect of low, middle and high dose of SAL0120 versus placebo on seated systolic blood pressure at Week 4, 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SAL0120 in people with Uncontrolled Hypertension and Resistant 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 12 inclusion and 8 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: finished, as of the sponsor's last update on 27 Aug 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Seated Systolic Blood Pressure for low, middle and high dose of SAL0120 (time frame: at Week 12). The study lists 2 primary outcomes in all. 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 27 Aug 2026.