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Sitogilun Malate Plus Amlodipine in Patients With Hypertension and Risk of Early Kidney Damage
Sponsor: Shanghai Jiao Tong University School of Medicine
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.
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Sitogilun Malate Tablets Combined With Amlodipine Besylate Tablets in Patients With Mild to Moderate Essential Hypertension and Risk of Early Kidney Damage
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
456
Start Date
2026-09-22
Completion Date
2028-12-31
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
Sitogilun Malate
Sitogilun malate tablets, 100 mg orally once daily for 8 weeks.
Allisartan Isoproxil
Allisartan isoproxil tablets, 240 mg orally once daily for 8 weeks.
Amlodipine besylate
Amlodipine besylate tablets, 5 mg orally once daily for 8 weeks.
Sitogilun Malate Placebo
Matching placebo for sitogilun malate, two tablets orally once daily for 8 weeks.
Allisartan Isoproxil Placebo
Matching placebo for allisartan isoproxil, one tablet orally once daily for 8 weeks.
Locations (1)
Ruijin Hospital
Shanghai, China, China