Sitogilun Malate with Amlodipine in High Blood Pressure with Early Kidney Risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, parallel-phase 4 study comparing sitogilun malate plus amlodipine, allisartan isoproxil plus amlodipine, and placebo plus amlodipine in about 456 adults with mild-to-moderate essential hypertension and a UACR of 15-30 mg/g. Participants will be assigned 1:1:1 and followed for 8 weeks to assess changes in mean sitting diastolic and systolic blood pressure, BP response and control rates, ambulatory BP parameters, and urinary albumin-to-creatinine ratio, alongside safety monitoring. The trial is conducted at Ruijin Hospital in Shanghai, led by Shanghai Jiao Tong University School of Medicine. The primary outcome is change in msDBP at Week 8; secondary outcomes include msSBP changes and other BP-related measures. Safety outcomes will be collected throughout the study period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ruijin Hospital
  Shanghai, China, China Recruiting

Study contacts

• Study coordinator: Ji-guang Wang, MD, PhD
• Email: jiguangw@163.com
• Phone: 021 64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.