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

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 Overview

• Status: Not yet recruiting
• Conditions: Mild-to-moderate Essential Hypertension
• Intervention / Treatment: Drug: SYH9056; Drug: Levamlodipine; Drug: Levamlodipine placebo; Drug: SYH9056 placebo; Drug: Valsartan; Drug: valsartan placebo

• Study Type: Interventional
• Enrollment (Estimated): 606
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 86-0311-69085587; Email: ctr-contact@cspc.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-75 (inclusive) years old;
2. 18.0 kg/m^2 ≤ BMI ≤ 35.0 kg/m^2 and ≥ 50 kg for men and ≥ 45 kg for women at screening;
3. Diagnosis of mild or moderate essential hypertension;

4. Office blood pressure measurements meet any of the following at the time of screening:

   ① Patients who have not used any antihypertensive medication for at least 4 weeks prior to screening, with an average office sitting blood pressure (average of 3 measurements) of 150 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg;

   ② Patients who have been using a stable dose of one or two component of antihypertensive medications (including single agents, two-drug combination or two-component combinations) for at least 4 weeks prior to screening, and who, in the judgment of the clinician, can be switched to levlevamlodipine maleate tablets (2.5 mg/day) or valacyclovir capsules (80 mg/day), and whose mean office sitting blood pressure meets 140 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg;

5. Prior to randomization, mean office sitting blood pressure meets 140 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg;
6. Medication adherence between 80% and 120% (including borderline values) during the introductory period.

Exclusion Criteria:

1. Rrefractory hypertension, hypertensive emergencies, hypertensive sub-emergencies and secondary hypertension;
2. Allergy (≥ 3 drug or food allergies) or known hypersensitivity to levamlodipine, levlevamlodipine, valsartan and related drugs (dihydropyridine calcium channel blockers, angiotensin II receptor blockers);
3. History of malignancy within the last 5 years (with the exception of cured basal cell carcinoma of the skin, limited squamous cell carcinoma of the skin, or cervical cancer in situ), or an underlying malignancy currently under evaluation;
4. Known or suspected symptomatic upright/postural hypotension ;
5. Uncontrolled diabetes mellitus;
6. Abnormal thyroid function;
7. Severe cardiovascular or cerebrovascular disease within 6 months prior to screening or randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYH9056（levamlodipine cohort）; Subjects will receive SYH9056 plus levamlodipine placebo for 12 weeks following a 4-weeks run-in period of levamlodipine treatment, then switch to SYH9056 treatment for 12 weeks	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: Levamlodipine placebo; PO once daily
Active Comparator: Levamlodipine（levamlodipine cohort）; Subjects will receive levamlodipine plus SYH9056 placebo for 12weeks following a 4-weeks run-in period of levamlodipine treatment, then switch to SYH9056 treatment for 12 weeks	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: SYH9056 placebo; PO once daily
Active Comparator: SYH9056（valsartan cohort）; Subjects will receive SYH9056 plus valsartan placebo for 12 weeks following a 4-weeks run-in period of valsartan treatment, then switch to SYH9056 treatment for 12 weeks	Drug: SYH9056; PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan; Drug: Valsartan; 80mg PO once daily; Drug: valsartan placebo; PO once daily
Active Comparator: Valsartan（valsartan cohort）; Subjects will receive valsartan plus SYH9056 placebo for 12weeks following a 4-weeks run-in period of valsartan treatment, then switch to SYH9056 treatment for 12 weeks	Drug: SYH9056; PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan; Drug: SYH9056 placebo; PO once daily; Drug: Valsartan; 80mg PO once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Week 12

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 24, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Essential Hypertension; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Micronutrients; Vitamin B Complex; Vitamins; Vasodilator Agents; Antihypertensive Agents; Hypolipidemic Agents; Lipid Regulating Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Niacin
• Other Study ID Numbers: SYH9056-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No