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

CSPC Pharmaceutical Group

Status and phase: Not yet enrolling; Phase 3

Conditions: Mild-to-moderate Essential Hypertension

Treatments: Drug: SYH9056; Drug: Levamlodipine; Drug: valsartan placebo; Drug: SYH9056 placebo; Drug: Valsartan; Drug: Levamlodipine placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06771245

SYH9056-002

Details and patient eligibility

About

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.

Enrollment: 606 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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606 participants in 4 patient groups

SYH9056（levamlodipine cohort）

Experimental group

Description:

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

Treatment:

Drug: Levamlodipine placebo

Drug: Levamlodipine

Drug: SYH9056

Levamlodipine（levamlodipine cohort）

Active Comparator group

Description:

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

Treatment:

Drug: SYH9056 placebo

Drug: Levamlodipine

Drug: SYH9056

SYH9056（valsartan cohort）

Active Comparator group

Description:

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

Treatment:

Drug: Valsartan

Drug: valsartan placebo

Drug: SYH9056

Valsartan（valsartan cohort）

Active Comparator group

Description:

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

Treatment:

Drug: Valsartan

Drug: SYH9056 placebo

Drug: SYH9056