Can a new pill tame blood pressure that Won't budge?
NCT ID NCT07790120
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests an experimental pill called SAL0120, taken once a day, in adults whose blood pressure stays high even when they already take two or more blood pressure medicines. About 256 people aged 18 to 75 with uncontrolled or resistant hypertension will receive either a low, middle, or high dose of SAL0120 or a placebo for 12 weeks. Researchers will measure how much seated systolic blood pressure drops from the start of the study to see if the drug helps where current treatments fall short.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SAL0120 tablets taken by mouth once daily
- What this could lead to
- If SAL0120 works, it could offer a new daily pill option for people whose blood pressure stays high despite taking two or more medications.
- What could go wrong
- This is an early-phase trial with a modest number of participants, so the drug may not prove effective or safe enough for wider use. Blood pressure responses vary, and side effects are possible.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
256 people
The number who actually took part.
- Started
-
Oct 2024
- Finished
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Jul 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 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. Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
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Other studies related to the condition(s) this trial covers.
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