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

NCT ID: NCT06771245

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 606 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-24
• Study Completion Date: 2026-10-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

SYH9056

Intervention Type: DRUG

PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan

Levamlodipine

Intervention Type: DRUG

2.5mg PO once daily

Levamlodipine placebo

Intervention Type: DRUG

PO once daily

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

Group Type: ACTIVE_COMPARATOR

SYH9056

Intervention Type: DRUG

PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan

Levamlodipine

Intervention Type: DRUG

2.5mg PO once daily

SYH9056 placebo

Intervention Type: DRUG

PO once daily

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

Group Type: ACTIVE_COMPARATOR

SYH9056

Intervention Type: DRUG

PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan

Valsartan

Intervention Type: DRUG

80mg PO once daily

valsartan placebo

Intervention Type: DRUG

PO once daily

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

Group Type: ACTIVE_COMPARATOR

SYH9056

Intervention Type: DRUG

PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan

Valsartan

Intervention Type: DRUG

80mg PO once daily

SYH9056 placebo

Intervention Type: DRUG

PO once daily

Interventions

SYH9056

PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan

Intervention Type: DRUG

Levamlodipine

2.5mg PO once daily

Intervention Type: DRUG

Valsartan

80mg PO once daily

Intervention Type: DRUG

SYH9056 placebo

PO once daily

Intervention Type: DRUG

Levamlodipine placebo

PO once daily

Intervention Type: DRUG

valsartan placebo

PO once daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@cspc.cn

86-0311-69085587

Other Identifiers

SYH9056-002

Identifier Type: -

Identifier Source: org_study_id