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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
606
PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan
2.5mg PO once daily
80mg PO once daily
PO once daily
PO once daily
PO once daily
Absolute change from baseline in mean sitting systolic blood pressure at Week 12
systolic blood pressure were measured in a sitting position after at least 5 minutes of rest at scheduled time points.
Time frame: At Week 12
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