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NOT YET RECRUITING
NCT06771245
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

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