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A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets In Hypertensive Patients

StatusNot Yet Recruiting
PhasePhase 3
Started2025-01-24
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 13, 2025 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.
SYH9056 tablets are a combination of valsartan and levamlodipine maleate. This is a multicenter, randomized, double-blind, parallel-controlled phase III study, designed to validate the efficacy and safety of SYH9056 tablets in patients with mild-to-moderate essential hypertension not controlled after 4 weeks of treatment with either levamlodipine maleate tablets or valsartan capsules, using either levamlodipine maleate tablets or valsartan capsules as a control. The study consisted of 4 phases: a screening period (2 weeks), an introduction period (4 weeks), a core treatment period (12 weeks), an extended treatment period (12 weeks), and a safety follow-up period (1 week), totaling approximately 31 weeks.
Trial Details
NCT Number NCT06771245
Lead Sponsor CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions Mild-to-moderate Essential Hypertension
Enrollment 606 participants
Start Date 2025-01-24
Primary Completion 2026-03-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2025-01-13