Overview

This is a multicenter, randomized, double-blind, parallel-controlled Phase IV clinical trial designed to evaluate the efficacy and safety of sitogilun malate tablets in combination with amlodipine besylate tablets in patients with mild to moderate essential hypertension and risk of early kidney damage. Approximately 456 eligible participants will be randomized in a 1:1:1 ratio to receive sitogilun malate plus amlodipine, allisartan isoproxil plus amlodipine, or placebo plus amlodipine for 8 weeks. The primary efficacy outcome is the change from baseline in mean sitting diastolic blood pressure (msDBP) at Week 8. Secondary efficacy outcomes include changes in mean sitting systolic blood pressure (msSBP), blood pressure response and control rates, ambulatory blood pressure parameters, and urinary albumin-to-creatinine ratio (UACR). Safety will also be evaluated throughout the study.

Eligibility

Inclusion Criteria:

1. Aged ≥18 years.
2. Male or female.
3. Diagnosed with mild to moderate essential hypertension (Grade 1 or Grade 2 hypertension). At both screening and prior to randomization, seated diastolic blood pressure (DBP) must be 90-109 mmHg, with or without seated systolic blood pressure (SBP) of 140-179 mmHg.
4. Urinary albumin-to-creatinine ratio (UACR) of 15-30 mg/g, inclusive, at both screening and prior to randomization.
5. Fully understands the study and voluntarily agrees to participate and provides written informed consent.

Exclusion Criteria:

1. Secondary hypertension, as determined by the investigator.
2. Severe cardiac disease within 6 months prior to screening, including chronic congestive heart failure (NYHA Class III or IV), acute myocardial infarction, unstable angina, cardiogenic shock, arrhythmias requiring treatment, valvular heart disease, hypertrophic cardiomyopathy, or rheumatic heart disease.
3. Severe cerebrovascular disease or events within 6 months prior to screening, including hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, or transient ischemic attack.
4. History of Takayasu arteritis, aortic aneurysm, aortic dissection, unilateral or bilateral renal artery stenosis, or severe subclavian artery stenosis.
5. Diagnosed or suspected primary glomerulonephritis, renal involvement due to autoimmune disease, diabetic kidney disease, polycystic kidney disease, or other diseases that may cause an elevated UACR at screening.
6. Laboratory abnormalities at screening, including alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 × the upper limit of normal (ULN), estimated glomerular filtration rate (eGFR) \<30 mL/min, or hemoglobin \<90 g/L.
7. Serum potassium \>5.5 mmol/L at screening.
8. Poorly controlled diabetes mellitus, defined as fasting blood glucose \>11 mmol/L at screening.
9. Current or previous diagnosis of hyperthyroidism or hypothyroidism, except for resolved thyroid dysfunction or subclinical hyperthyroidism/hypothyroidism.
10. History of gastrointestinal surgery that may significantly alter drug absorption, distribution, metabolism, or excretion.
11. Major surgery within 3 months prior to screening or planned major surgery during the study.
12. History of malignancy within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal-cell or squamous-cell skin cancer, localized prostate cancer after curative surgery, or papillary thyroid carcinoma.
13. Planned use during the study of antihypertensive medications or other medications known to affect blood pressure, such as monoamine oxidase inhibitors, corticosteroids, nonsteroidal anti-inflammatory drugs, oral contraceptives, or antidepressants.
14. Abnormal daily sleep-wake schedule (e.g., reversal of the normal day-night schedule) that, in the investigator's judgment, may affect blood pressure.
15. Hypersensitivity to any study drug or its excipients, or a history of hypersensitivity to angiotensin II receptor blockers or calcium channel blockers.
16. History of drug abuse or alcohol abuse within 1 year prior to screening.
17. Participation as a study participant in another drug or medical device clinical trial within 1 month prior to screening.
18. Pregnant or breastfeeding women, or participants or their partners planning pregnancy during the study or within 6 months after completion of the study.
19. Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.