Uncontrolled or Resistant HypertensionPhase 2/3NCT07708441
A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
A Phase 2/3 study testing HRS-1780 tablet in people with Uncontrolled or Resistant Hypertension, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension. To explore the optimal use of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension。 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uncontrolled or Resistant Hypertension
- What is being tested?
- HRS-1780 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 914 participants
- Where
- 2 sitesChina
- Study dates
- 29 Sep 2026to Apr 2029
- Phase
- Phase 2/3
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥ 18 and < 80 years ；
- Mean trough seated SBP ≥ 140 mmHg and < 170 mmHg at both screening and randomization visits.
- Meet one of the following two criteria:
- Meet the criteria for uncontrolled hypertension；
- Meet the criteria for resistant hypertension；
- Serum potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L ；
- Voluntarily sign the ICF prior to the study；
- Have no plan for fertility from the time of signing the ICF until 4 weeks after the last dose.
Who cannot join
- Mean trough seated DBP ≥ 110 mmHg at randomization.
- Have a known secondary cause of hypertension, including but not limited to: renal artery stenosis, coarctation of the aorta, uncontrolled or untreated hyperthyroidism/hypothyroidism, pheochromocytoma, or Cushing's syndrome.
- History of adrenal insufficiency at screening.
- Presence of severe structural heart disease at screening, including severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, rheumatic heart disease, or congenital heart disease.
- Presence of persistent atrial fibrillation or any arrhythmia requiring treatment at screening; or resting heart rate < 45 bpm or > 110 bpm.
- New York Heart Association (NYHA) Class III-IV heart failure at screening.
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- Undergone CT angiography (CTA) or colonoscopy within 1 month prior to screening.
- Undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months prior to screening, or plan to undergo PCI, CABG, carotid or peripheral artery revascularization during the study period.
- History of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalization for heart failure within 6 months prior to screening.
- Within 6 months prior to screening, presence of clinically significant diseases in the following systems that, in the investigator's judgment, may interfere with the study results or pose additional risk to the administration of the investigational product, including but not limited to: respiratory, digestive, endocrine, immune, urinary, hematologic, neurologic, or psychiatric disorders.
- History of malignancy within 5 years prior to screening.
- Use of strong inhibitors/inducers of cytochrome P450 3A4 (CYP3A4) within 1 week prior to screening ,or moderate inhibitors/inducers.
- Use of mineralocorticoid receptor antagonists (MRAs) and/or potassium-sparing diuretics (e.g., spironolactone, eplerenone, finerenone, amiloride, triamterene, etc.) within 4 weeks prior to randomization.
- Use of aldosterone synthase inhibitors (ASIs) within 4 weeks prior to randomization.
- Concomitant use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) within 4 weeks prior to randomization.
- Treatment with potassium binders within 2 months prior to screening.
- Presence of any of the following laboratory abnormalities:
- eGFR < 45 mL/min/1.73 m² ;
- HbA1c > 10.5%;
- Serum sodium < 135.0 mmol/L;
- ALT ≥ 3 × ULN;
- AST ≥ 3 × ULN;
- Total bilirubin ≥ 2 × ULN.
- Body mass index (BMI) > 35 kg/m².
- Run-in period placebo compliance < 80% or > 120% at randomization.
- Known or suspected allergy to MRAs, the investigational product, or any of its excipients.
- Treatment with any other investigational product within 90 days or 5 half-lives prior to screening .
- Women of childbearing potential (WOCBP) who are pregnant, breastfeeding, plan to become pregnant during the study, or are unable to use highly effective contraceptive measures; or male participants who are unable to use highly effective contraceptive measures.
- Occupation or working schedule requiring regular night shifts or similar circumstances that may interfere with study procedures.
- Any other condition that, in the investigator's judgment, may compromise participant safety or interfere with the assessment of study results.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Army Characteristic Medical Center of the People's Liberation Army
Chongqing, Chongqing Municipality, 400042
Chunyu Zeng
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200080
Xiaoqiang Ding
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
The study is being conducted to evaluate the efficacy and safety of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension. To explore the optimal use of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension。
- Conditions
- Uncontrolled or Resistant Hypertension
- Being tested
- HRS-1780 tablet, HRS-1780 tablet placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1780 tabletDrug
HRS-1780 tablet Dose 1
HRS-1780 tabletDrug
HRS-1780 tablet Dose 2
HRS-1780 tabletDrug
HRS-1780 tablet Dose 3
HRS-1780 tablet placeboDrug
HRS-1780 tablet placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-1780 tablet Dose 1 | Experimental | Not described Receives: Drug: HRS-1780 tablet |
| Treatment group B: HRS-1780 tablet Dose 2 | Experimental | Not described Receives: Drug: HRS-1780 tablet |
| Treatment group C: HRS-1780 tablet Dose 3 | Experimental | Not described Receives: Drug: HRS-1780 tablet |
| Treatment group D: HRS-1780 tablet placebo | Placebo comparator | Not described Receives: Drug: HRS-1780 tablet placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in trough seated SBP at Week 12
Measured: baseline and Week 12
Secondary outcomes (12)
Change from baseline in trough seated DBP at Week 12
Measured: baseline and Week 12
Change from baseline in trough seated SBP at Week 8
Measured: baseline and Week 8
Proportion of participants achieving trough seated blood pressure < 140/90 mmHg at Week 12
Measured: Week 12
Proportion of participants achieving trough seated SBP < 130 mmHg at Week 12
Measured: Week 12
Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP at Week 12
Measured: baseline and Week 12
Change from baseline in daytime and nighttime mean SBP measured by 24-hour ABPM at Week 12
Measured: baseline and Week 12
Change from baseline in daytime and nighttime mean DBP measured by 24-hour ABPM at Week 12
Measured: baseline and Week 12
Change from randomized withdrawal baseline (Week 44) in trough seated SBP at Week 52
Measured: Week 44 and Week 52
Proportion of participants with eGFR decline ≥ 30% during the treatment period
Measured: baseline and treatment period
Proportion of participants with serum potassium > 6.0 mmol/L during the treatment period
Measured: treatment period
Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean DBP at Week 12
Measured: baseline and Week 12
Proportion of participants with serum potassium > 5.5 mmol/L and ≤ 6.0 mmol/L during the treatment period
Measured: treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start29 Sep 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled or Resistant 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 914 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708441
- Sponsor's protocol ID
- HRS-1780-302
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided