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

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.

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