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

NCT06771245 | Not Yet Recruiting Phase 3

• 1 other identifier: SYH9056-002
• Study Type: interventional
• Target: 606
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

SYH9056（levamlodipine cohort）

EXPERIMENTAL

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; Drug: Levamlodipine; Drug: Levamlodipine placebo

Levamlodipine（levamlodipine cohort）

ACTIVE COMPARATOR

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; Drug: Levamlodipine; Drug: SYH9056 placebo

SYH9056（valsartan cohort）

ACTIVE COMPARATOR

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; Drug: Valsartan; Drug: valsartan placebo

Valsartan（valsartan cohort）

ACTIVE COMPARATOR

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; Drug: Valsartan; Drug: SYH9056 placebo

Interventions

SYH9056 DRUG

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

Levamlodipine（levamlodipine cohort）; SYH9056（levamlodipine cohort）; SYH9056（valsartan cohort）; Valsartan（valsartan cohort）

Levamlodipine DRUG

2.5mg PO once daily

Levamlodipine（levamlodipine cohort）; SYH9056（levamlodipine cohort）

Valsartan DRUG

80mg PO once daily

SYH9056（valsartan cohort）; Valsartan（valsartan cohort）

SYH9056 placebo DRUG

PO once daily

Levamlodipine（levamlodipine cohort）; Valsartan（valsartan cohort）

Levamlodipine placebo DRUG

PO once daily

SYH9056（levamlodipine cohort）

valsartan placebo DRUG

PO once daily

SYH9056（valsartan cohort）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (inclusive) years old;
• kg/m\^2 ≤ BMI ≤ 35.0 kg/m\^2 and ≥ 50 kg for men and ≥ 45 kg for women at screening;
• Diagnosis of mild or moderate essential hypertension;
• 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;
• Prior to randomization, mean office sitting blood pressure meets 140 mmHg ≤ SBP \< 180 mmHg and DBP \< 110 mmHg;
• Medication adherence between 80% and 120% (including borderline values) during the introductory period.

You may not qualify if:

• Rrefractory hypertension, hypertensive emergencies, hypertensive sub-emergencies and secondary hypertension;
• Allergy (≥ 3 drug or food allergies) or known hypersensitivity to levamlodipine, levlevamlodipine, valsartan and related drugs (dihydropyridine calcium channel blockers, angiotensin II receptor blockers);
• 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;
• Known or suspected symptomatic upright/postural hypotension ;
• Uncontrolled diabetes mellitus;
• Abnormal thyroid function;
• Severe cardiovascular or cerebrovascular disease within 6 months prior to screening or randomization.

Sponsors & Collaborators

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

MeSH Terms

Interventions

levamlodipine; Valsartan

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, double-blind, parallel-controlled phase III study. Approximately 606 participants will be enrolled, including approximately 410 in the levamlodipine maleate cohort and 196 in the valsartan cohort, each of which was randomized in a 1:1 ratio to receive SYH9056 tablets or levamlodipine maleate tablets or valsartan capsules as monotherapy.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: January 24, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 13, 2025

Record last verified: 2024-12