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

Launched by CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY CO., LTD. · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SYH9056, which combines two existing drugs, valsartan and levamlodipine, to help control high blood pressure in adults with mild to moderate essential hypertension. The trial is designed for patients who have not achieved good blood pressure control after four weeks of treatment with either of the two drugs alone. It will involve several phases over approximately 31 weeks, including screening, treatment, and follow-up to ensure that the medication is both effective and safe.

To be eligible for this trial, participants need to be between 18 and 75 years old and have a certain level of high blood pressure that hasn't been well managed. They should not have certain health conditions, like severe high blood pressure emergencies or allergies to the study medications. If you join the study, you'll be monitored closely to see how well the medication works and if you experience any side effects. This trial is not yet recruiting participants, but if you're interested, it could be an opportunity to contribute to research aimed at improving treatment for high blood pressure.

Gender

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Eligibility criteria

• 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.