Health TrialsbyHealthPanel

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

ConditionMild-to-moderate Essential Hypertension
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-75 (inclusive) years old;

18.0 kg/m² ≤ BMI ≤ 35.0 kg/m² and ≥ 50 kg for men and ≥ 45 kg for women at screening;

Diagnosis of mild or moderate essential hypertension;

Prior to randomization, mean office sitting blood pressure meets 140 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg;

Disqualifiers

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 ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYH9056

    Drug

    PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan

  • 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

Treatment groups

606 Participants
are divided into 4 treatment groups
Group A: SYH9056（levamlodipine cohort）Experimental treatment 3 interventions
Group B: Levamlodipine（levamlodipine cohort）Active comparator 3 interventions
Group C: SYH9056（valsartan cohort）Active comparator 3 interventions
Group D: Valsartan（valsartan cohort）Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: