Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYH9056 | Drug | PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
18-75 (inclusive) years old;
18.0 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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| Levamlodipine | Drug | 2.5mg PO once daily |
|
| Valsartan | Drug | 80mg PO once daily |
|
| SYH9056 placebo | Drug | PO once daily |
|
| Levamlodipine placebo | Drug | PO once daily |
|
| valsartan placebo | Drug | PO once daily |
|
| ID | Term |
|---|---|
| C542574 | levamlodipine |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
Not provided
Not provided