A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056… (NCT06771245) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets In Hypertensive Patients
606 participantsStarted 2025-01-24
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute change from baseline in mean sitting systolic blood pressure at Week 12
. 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.