uncontrolled hypertension or resistant hypertension
Conditions
Interventions
Phase II HRS-1780 10 mg group:HRS- 1780 10mg
Phase II placebo arm:placebo tablet
Phase III placebo group:placebo tablet
Phase III HRS-1780 low?dose group:HRS-1780 low?dose group
Phase II HRS-1780 40?mg group:HRS- 1780 40mg
Phase III HRS-1780 high?dose group:HRS-1780 high?dose
Phase II HRS-1780 20?mg group:HRS- 1780 20mg
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Male or female, aged =18 and <80 years on the day of signing the informed consent form (ICF). 2.Mean seated office systolic blood pressure (SBP) =140 mmHg and <170 mmHg at both screening and randomization visits. 3.Meeting one of the following two criteria:; 1.a) Criteria for uncontrolled hypertension: on stable treatment with two different classes of antihypertensive agents (one of which must be a diuretic) at the maximum tolerated dose, as determined by the investigator, for at least 4 weeks prior to screening; or; 2.b) Criteria for resistant hypertension: on stable treatment with three or more different classes of antihypertensive agents (one of which must be a diuretic) at the maximum tolerated dose, as determined by the investigator, for at least 4 weeks prior to screening. 4. 4.Serum potassium =3.5 mmol/L and =5.0 mmol/L at both screening and randomization visits. 5.Provision of written informed consent before any trial-related procedures, with a full understanding of the trial content, procedures, and potential adverse events, and willingness and ability to comply with all protocol requirements throughout the trial. 6.Agreement to refrain from procreation and to use highly effective contraceptive measures as specified in the protocol from the time of signing the ICF through 4 weeks after the last dose of the investigational product.
Exclusion criteria
Exclusion criteria: 1.Mean seated office diastolic blood pressure (DBP) =110 mmHg at randomization. 2.Presence of any of the following known secondary causes of hypertension: renal artery stenosis (excluding mild stenosis, defined as 110 beats per minute. 6.New York Heart Association (NYHA) functional class III or IV at screening. 7.Undergone computed tomography angiography (CTA) or colonoscopy within 1 month before screening. 8.Undergone percutaneous coronary intervention or coronary artery bypass grafting within 6 months before screening, or planned to undergo such procedures or carotid/peripheral artery revascularization during the trial. 9.History of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalization for heart failure within 6 months before screening. 10.Presence of any clinically significant disease of the respiratory, digestive, endocrine, immune, urinary, hematologic, neurologic, or psychiatric systems within 6 months before screening that, in the investigator's judgment, may interfere with the trial results or pose additional risk with the investigational product. 11.History of malignancy within 5 years before screening (except for cured cervical carcinoma in situ, localized basal cell carcinoma of the skin, and papillary thyroid carcinoma). 12.Use of strong or moderate inhibitors/inducers of cytochrome P450 3A4 (CYP3A4) within 1 week before screening (strong inhibitors include, but are not limited to, itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin, or nefazodone; strong inducers include carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.). 13.Use of mineralocorticoid receptor antagonists (MRAs) and/or potassium-sparing diuretics (e.g., spironolactone, eplerenone, finerenone, amiloride, and triamterene) within 4 weeks before randomization. 14.Use of aldosterone synthase inhibitors (ASIs) within 4 weeks before randomization. 15.Concomitant use of an angiotensin-converting enzyme inhibitor (ACEI) and an angiotensin II receptor blocker (ARB) within 4 weeks before randomization. 16.Treatment with potassium-binding agents within 2 months before screening. 17.Any of the following laboratory findings at screening:; 18.a) Estimated glomerular filtration rate (eGFR) 10.5%; 20.c) Serum sodium 35 kg/m². 25.Adherence to placebo during the run-in period 120% at randomization. 26.Known or suspected hypersensitivity to MRAs or to the investigational product or its excipients. 27.Treatment with any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic blood pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diastolic Blood Pressure;serum potassium;Ambulatory Blood Pressure Monitoring;Estimated Glomerular Filtration Rate; | — |
Countries
China
Contacts
Public ContactZeng Chunyu
Army Medical Center of PLA
Outcome results
None listed