Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07876544
PHASE4

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

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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

DRUG

Sitogilun Malate

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

DRUG

Allisartan Isoproxil

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

DRUG

Amlodipine besylate

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

DRUG

Sitogilun Malate Placebo

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

DRUG

Allisartan Isoproxil Placebo

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

Locations (1)

Ruijin Hospital

Shanghai, China, China