Uncontrolled HypertensionPhase 2NCT07911735
A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
A Phase 2 study testing SYH2072 Tablets in people with Uncontrolled Hypertension and Resistant Hypertension, run by InnovStone Therapeutics Limited.
Trial summary
SYH2072 is a highly selective aldosterone synthase inhibitor. This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of SYH2072 tablets in patients with uncontrolled hypertension (including patients with resistant hypertension) receiving stable… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Hypertension, Resistant Hypertension
- What is being tested?
- SYH2072 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- No sites listed yet
- Study dates
- 13 Dec 2026to 28 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this study and sign the informed consent form.
- Age ≥ 18 years at the time of screening, male or female.
- Mean seated systolic blood pressure (msSBP) at screening was ≥140 mmHg and <180 mmHg.
- During the run-in period, adherence to baseline antihypertensive medications and study medications ranged from 80% to 120% (including the boundary values);
- There were no changes in the types or doses of baseline antihypertensive medications prior to randomization, and no rescue therapy was administered.
Who cannot join
- Known causes of secondary hypertension: renal artery stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, aortic coarctation, etc.;
- Allergic constitution (allergies to ≥3 types/classes of drugs or foods); or known allergy to aldosterone synthase inhibitors or background antihypertensive medications;
- History of malignancy within the past 5 years, or a potential malignancy currently under evaluation;
- Type 2 diabetes with poor glycemic control, unstable antidiabetic treatment regimens within 4 weeks prior to screening, or type 1 diabetes;
- Hyperthyroidism or hypothyroidism requiring immediate treatment or medication adjustment; or subclinical hypothyroidism with a TSH level >10.0 mIU at screening or requiring medication as assessed by the investigator;
- Severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
- Individuals who plan to conceive (including through sperm or egg donation) from the signing of the ICF until 3 months after the last dose of the investigational drug, and/or who do not agree to use effective non-pharmacological contraception;
- Pregnant or breastfeeding women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of SYH2072 Tablets for Uncontrolled Hypertension (Including Resistant Hypertension) in Patients on Two or More Antihypertensive Agents
SYH2072 is a highly selective aldosterone synthase inhibitor. This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of SYH2072 tablets in patients with uncontrolled hypertension (including patients with resistant hypertension) receiving stable treatment with two or more antihypertensive agents.
- Conditions
- Uncontrolled Hypertension, Resistant Hypertension
- Being tested
- SYH2072 Tablets, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2072 TabletsDrug
Low-dose
SYH2072 TabletsDrug
Middle-dose
SYH2072 TabletsDrug
high-dose
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | SYH2072 Tablets Receives: Drug: SYH2072 Tablets |
| Middle-dose group | Experimental | SYH2072 Tablets Receives: Drug: SYH2072 Tablets; Drug: placebo |
| High-dose group | Experimental | SYH2072 Tablets Receives: Drug: SYH2072 Tablets |
| Placebo group | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 posted3 Nov 2026
- Study start13 Dec 2026 (estimated)
- Primary completion22 Jul 2027 (estimated)
- Study completion28 Nov 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.
- 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
- Model description
- This is a parallel-group design. Participants diagnosed with uncontrolled hypertension will be randomly assigned to the SYH2072 low-dose, middle-dose, high-dose, or placebo group during the double-blind treatment period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnovStone Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- officer, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911735
- Sponsor's protocol ID
- SYH2072-003
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 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 Trial of SYH2072 Tablets for Uncontrolled Hypertension (Including Resistant Hypertension) in Patients on Two or More Antihypertensive Agents
- ClinicalTrials.gov ID
- NCT07911735
- Acronym / sponsor ID
- SYH2072-003
- Conditions
- Uncontrolled Hypertension, Resistant Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- InnovStone Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2026 (estimated)
- Primary completion
- 22 Jul 2027 (estimated)
- Study completion
- 28 Nov 2027 (estimated)
- First posted
- 3 Nov 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.
SYH2072 is a highly selective aldosterone synthase inhibitor. This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of SYH2072 tablets in patients with uncontrolled hypertension (including patients with resistant hypertension) receiving stable treatment with two or more antihypertensive agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a parallel-group design. Participants diagnosed with uncontrolled hypertension will be randomly assigned to the SYH2072 low-dose, middle-dose, high-dose, or placebo group during the double-blind treatment period.
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: SYH2072 TabletsSYH2072 Tablets |
| Middle-dose group | Experimental | Drug: SYH2072 Tablets, Drug: placeboSYH2072 Tablets |
| High-dose group | Experimental | Drug: SYH2072 TabletsSYH2072 Tablets |
| Placebo group | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily participate in this study and sign the informed consent form.
- Age ≥ 18 years at the time of screening, male or female.
- Mean seated systolic blood pressure (msSBP) at screening was ≥140 mmHg and <180 mmHg.
- During the run-in period, adherence to baseline antihypertensive medications and study medications ranged from 80% to 120% (including the boundary values);
- There were no changes in the types or doses of baseline antihypertensive medications prior to randomization, and no rescue therapy was administered.
Key exclusion criteria (8 listed)
- Known causes of secondary hypertension: renal artery stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, aortic coarctation, etc.;
- Allergic constitution (allergies to ≥3 types/classes of drugs or foods); or known allergy to aldosterone synthase inhibitors or background antihypertensive medications;
- History of malignancy within the past 5 years, or a potential malignancy currently under evaluation;
- Type 2 diabetes with poor glycemic control, unstable antidiabetic treatment regimens within 4 weeks prior to screening, or type 1 diabetes;
- Hyperthyroidism or hypothyroidism requiring immediate treatment or medication adjustment; or subclinical hypothyroidism with a TSH level >10.0 mIU at screening or requiring medication as assessed by the investigator;
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 |
|---|---|---|
| SYH2072 TabletsLow-dose | Drug | Low-dose group |
| SYH2072 TabletsMiddle-dose | Drug | Middle-dose group |
| SYH2072 Tabletshigh-dose | Drug | High-dose group |
| placeboplacebo | Drug | Middle-dose group, Placebo group |
Primary outcome
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 4 Nov 2026.
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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.
officer study chair
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYH2072 Tablets in people with Uncontrolled Hypertension and Resistant Hypertension, run by InnovStone Therapeutics Limited.
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 5 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Clinical Trials Information Group NA officer (86-311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 4 Nov 2026.