Mild-to-moderate Essential Hypertension
Conditions
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.
Interventions
DRUGSYH9056
PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan
DRUGLevamlodipine
2.5mg PO once daily
DRUGValsartan
80mg PO once daily
DRUGSYH9056 placebo
PO once daily
PO once daily
PO once daily
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change from baseline in mean sitting systolic blood pressure at Week 12 | At Week 12 | systolic blood pressure were measured in a sitting position after at least 5 minutes of rest at scheduled time points. |
Contacts
Primary ContactClinical Trials Information Group officer
Outcome results
None listed