NCT06771245

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 606 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild-to-moderate Essential Hypertension

Interventions

Type	Name	Description
DRUG	SYH9056	PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan
DRUG	Levamlodipine	2.5mg PO once daily
DRUG	Valsartan	80mg PO once daily
DRUG	SYH9056 placebo	PO once daily
DRUG	Levamlodipine placebo	PO once daily
DRUG	valsartan placebo	PO once daily

Timeline

• Start date: 2025-01-24
• Primary completion: 2026-03-30
• Completion: 2026-10-30
• First posted: 2025-01-13
• Last updated: 2025-01-13