Efficacy and Safety of Metoprolol Succinate Prolonged-Release Tablet in Patients With Mild to Moderate Hypertension

Study Overview
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Brief Summary
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This is an open-label, non-comparative, multi-centre clinical study to evaluate the Efficacy and safety of Metoprolol Succinate prolonged-release tablet (Betaloc Zok) in patients with mild to moderate essential hypertension.

Official Title
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An Open-Label, Non-Comparative, Multi-Centre Study to Evaluate the Efficacy and Safety of Metoprolol Succinate Prolonged-Release Tablet (Betaloc Zok) in Patients With Mild to Moderate Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: metoprolol succinate prolonged-release tablet and felodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written informed consent Newly diagnosed essential hypertension who have not received anti- hypertensive treatment, or patients without antihypertensive medication in two weeks before screening, 90mmHg<SiDBP <110mmHg and SiSBP <180mmHg. Exclusion Criteria: Known or suspected secondary hypertension Resting HR is < 55bpm. Sick sinus syndrome Atrioventricular block of first degree (with P-R>0.24seconds), or second or third degree

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>The patients with mild to moderate essential hypertension | Drug: metoprolol succinate prolonged-release tablet and felodipine<br>* a regimen that starts with metoprolol succinate prolonged-release tablet 47.5mg once daily, orally and allows for dose escalation to 95mg once daily, orally at 4 weeks if not controlled; at week 8 allows for the addition of felodipine sustained release tablet 5mg once daily, orally<br>* Other names: Betaloc ZOK and Plendil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects reaching blood pressure target at wk 8 after metoprolol succinate prolonged release tablet treatment, and magnitude of systolic and diastolic blood pressure reduction from baseline among subjects who reached target (below 140/90mmHg). |  | Day -7- -1, Day1, Day 28, Day 56,Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The magnitude of systolic and diastolic blood pressure reduction from baseline among all the subjects at week 8 after metoprolol succinate prolonged release tablet treatment. |  | Day -7- -1, Day1, Day 28, Day 56,Day 84 | 
| The percentage of subjects reaching blood pressure target at week 4, and the magnitude of systolic and diastolic blood pressure reduction from baseline among all the subjects and those subjects who reached target |  | Day -7- -1, Day1, Day 28, Day 56,Day 84 | 
| The percentage of subjects reaching blood pressure target at week 12, and the magnitude of systolic and diastolic blood pressure reduction from baseline among all the subjects and those subjects who reached target |  | Day -7- -1, Day1, Day 28, Day 56,Day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post marketing study