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

Study acronym: SABER
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07876544
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)		 Hypertension
Related terms Hypertension
Enrollment 456 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov