Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets In Hypertensive Patients
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Summary
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.
Official title: A Multicenter, Randomized, Double-Blind Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets in Patients With Mild to Moderate Essential Hypertension Not Controlled After 4 Weeks of Monotherapy With Amlodipine Or Levamlodipine Alone
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
606
Start Date
2025-01-24
Completion Date
2026-10-30
Last Updated
2025-01-13
Healthy Volunteers
No
Conditions
Interventions
SYH9056
PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan
Levamlodipine
2.5mg PO once daily
Valsartan
80mg PO once daily
SYH9056 placebo
PO once daily
Levamlodipine placebo
PO once daily
valsartan placebo
PO once daily