Sitogilun Malate Plus Amlodipine in Patients With Hypertension and Risk of Early Kidney Damage

NCT07876544 | Recruiting Phase 4

• 1 other identifier: SABER
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8

  Mean sitting diastolic blood pressure (msDBP) will be measured in mmHg. The change from baseline to Week 8 will be calculated. A greater reduction in msDBP indicates a greater blood pressure-lowering effect.

  Baseline to Week 8

Secondary Outcomes (7)

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 4

  Baseline to Week 4

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 4

  Baseline to Week 4

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8

  Baseline to Week 8

• Overall Blood Pressure Response Rate at Weeks 4 and 8

  Weeks 4 and 8

• Blood Pressure Control Rate at Weeks 4 and 8

  Weeks 4 and 8

Study Arms (3)

Sitogilun Malate + Amlodipine

EXPERIMENTAL

Participants will receive sitogilun malate 100 mg (two 50-mg tablets), allisartan isoproxil placebo (one tablet), and amlodipine besylate 5 mg (one tablet) orally once daily for 8 weeks.

Drug: Sitogilun Malate; Drug: Amlodipine besylate; Drug: Allisartan Isoproxil Placebo

Allisartan Isoproxil + Amlodipine

ACTIVE COMPARATOR

Participants will receive sitogilun malate placebo (two tablets), allisartan isoproxil 240 mg (one tablet), and amlodipine besylate 5 mg (one tablet) orally once daily for 8 weeks.

Drug: Allisartan Isoproxil; Drug: Amlodipine besylate; Drug: Sitogilun Malate Placebo

Placebo + Amlodipine

PLACEBO COMPARATOR

Participants will receive sitogilun malate placebo (two tablets), allisartan isoproxil placebo (one tablet), and amlodipine besylate 5 mg (one tablet) orally once daily for 8 weeks.

Drug: Amlodipine besylate; Drug: Sitogilun Malate Placebo; Drug: Allisartan Isoproxil Placebo

Interventions

Sitogilun Malate DRUG

Sitogilun malate tablets, 100 mg orally once daily for 8 weeks.

Sitogilun Malate + Amlodipine

Allisartan Isoproxil DRUG

Allisartan isoproxil tablets, 240 mg orally once daily for 8 weeks.

Allisartan Isoproxil + Amlodipine

Amlodipine besylate DRUG

Amlodipine besylate tablets, 5 mg orally once daily for 8 weeks.

Allisartan Isoproxil + Amlodipine; Placebo + Amlodipine; Sitogilun Malate + Amlodipine

Sitogilun Malate Placebo DRUG

Matching placebo for sitogilun malate, two tablets orally once daily for 8 weeks.

Allisartan Isoproxil + Amlodipine; Placebo + Amlodipine

Allisartan Isoproxil Placebo DRUG

Matching placebo for allisartan isoproxil, one tablet orally once daily for 8 weeks.

Placebo + Amlodipine; Sitogilun Malate + Amlodipine

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years.
• Male or female.
• 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.
• Urinary albumin-to-creatinine ratio (UACR) of 15-30 mg/g, inclusive, at both screening and prior to randomization.
• Fully understands the study and voluntarily agrees to participate and provides written informed consent.

You may not qualify if:

• Secondary hypertension, as determined by the investigator.
• 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.
• Severe cerebrovascular disease or events within 6 months prior to screening, including hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, or transient ischemic attack.
• History of Takayasu arteritis, aortic aneurysm, aortic dissection, unilateral or bilateral renal artery stenosis, or severe subclavian artery stenosis.
• 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.
• 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.
• Serum potassium \>5.5 mmol/L at screening.
• Poorly controlled diabetes mellitus, defined as fasting blood glucose \>11 mmol/L at screening.
• Current or previous diagnosis of hyperthyroidism or hypothyroidism, except for resolved thyroid dysfunction or subclinical hyperthyroidism/hypothyroidism.
• History of gastrointestinal surgery that may significantly alter drug absorption, distribution, metabolism, or excretion.
• Major surgery within 3 months prior to screening or planned major surgery during the study.
• 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.
• 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.
• Abnormal daily sleep-wake schedule (e.g., reversal of the normal day-night schedule) that, in the investigator's judgment, may affect blood pressure.
• Hypersensitivity to any study drug or its excipients, or a history of hypersensitivity to angiotensin II receptor blockers or calcium channel blockers.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital

Shanghai, China, 200025, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

allisartan isoproxil; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ji-guang Wang, MD, PhD

CONTACT

021 64370045; jiguangw@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A double-dummy design will be used to maintain blinding. Participants will receive active sitogilun malate or matching placebo and active allisartan isoproxil or matching placebo, as applicable to the assigned treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension

Model Details: Eligible participants will be randomized in a 1:1:1 ratio to three parallel treatment groups to receive sitogilun malate plus amlodipine, allisartan isoproxil plus amlodipine, or placebo plus amlodipine for 8 weeks.

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start: September 22, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)