A Phase 3 interventional study of SYH9056 and Levamlodipine in Mild-to-moderate Essential Hypertension, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 3, Interventional, and Treatment
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.
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 166 studies on the registry; 47 are open to participants now.
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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;
Exclusion Criteria:
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
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
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
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
PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan
2.5mg PO once daily
80mg PO once daily
PO once daily
PO once daily
PO once daily
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.
Time frame: At Week 12
No study locations are listed for this record.
Start is estimated for Jan 2025; primary completion for Mar 2026, 14 months later.
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Levamlodipine
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