S-Metoprolol XR 25-50 mg Tablets vs Metoprolol Zok 50-100 mg Tablets in Hypertension Patients.

Study Overview
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Brief Summary
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The aim of this study is to compare the efficacy and safety of S-Metoprolol XR 25 and 50 mg Film Coated Tablets and Beloc® (Metoprolol) Zok 50 and 100 mg Controlled Release Film Tablets administered once daily, in the treatment of hypertension.

Official Title
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Comparison of Efficacy and Safety of S-Metoprolol XR 25-50 mg Tablets and Metoprolol Zok 50-100 mg Tablets in Hypertensive Patients.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Metoprolol
* Drug: Metoprolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients: between the ages of 18-70, Stage 1 and 2 hypertension patients who have not received any antihypertensive treatment in the past month * (≥ 140 mmHg SKB <180 mmHg, ≥ 90 mmHg DKB <110 mmHg, Patients with minute heart rate ≥ 70 / min, Patients followed up with outpatient treatment, Patients who give written informed consent without any influence, (Stage 1 Hypertension; SKB: 140-159 mmHg and DKB: 90-99 mmHg, Stage 2 Hypertension; SKB: 160--179 mmHg and DKB: 100--109 mmHg) Exclusion Criteria: Pregnant patients or breastfeeding mothers or women with childbearing potential who do not use any effective contraceptive methods, Patients with allergies or hypersensitivity to betabloker drugs, Patients who have received antihypertensive treatment in the past month, Patients with secondary hypertension, Patients who were followed up for the following diseases from the beginning of the study until the last 12 months, Severe hypertension (SKB> 180 mmHg and / or DKB> 110 mmHg), Myocardial infarction, NYHA stage 2-4 heart failure, Patients with a history of cerebrovascular disease, previous ischemic attack, encephalopathy, Patients undergoing percutaneous coronary intervention or coronary artery bypass surgery, 2nd or 3rd degree heart block or symptomatic arrhythmia without pacemaker, Clinically significant heart valve disease, Simultaneous life-threatening potential or symptomatic arrhythmia, Simultaneous unstable angina pectoris, Type 1 DM, Atrial fibrillation, Uncontrollable Type 2 DM (HbA1C> 7%), Patients with significant liver disease (initial ALT, AST> 2xULN, esophageal varices, portocaval shunt), Patients with significant kidney disease (GFR <60 ml / min according to the Cockcroft-Gault formula), Patients with volume depletion, Patients with pancreatic disease, Patients with gastrointestinal disease affecting absorption, Drug/substance and alcohol abuse in the last 12 months, Patients with central nervous system disease and using drugs for this reason, A history of incompatibility with medical regimens, or patients' unwillingness to comply with the study protocol, Patients directly involved in the management of this protocol.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>S-Metoprolol XR 25 mg Film Coated Tablets (first four weeks) S-Metoprolol XR 50 mg Film Coated Tablets (second four weeks) | Drug: Metoprolol<br>* S-Metoprolol XR 25 mg and 50 mg Film Coated Tablets<br>* Other names: S-metoprolol;|
| Active Comparator: REFERENCE<br>Beloc® (Metoprolol) Zok 50 mg Controlled Release Film Tablets (first four weeks) Beloc® (Metoprolol) Zok 100 mg Controlled Release Film Tablets (second four weeks) | Drug: Metoprolol<br>* Beloc® (Metoprolol) Zok 50 mg and 100 mg Controlled Release Film Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic and diastolic blood pressure between 0-4 weeks of treatment |  | 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure between 0-8 weeks of treatment. |  | 8-weeks | 
| Change in diastolic blood pressure between 0-8 weeks of treatment. |  | 8-weeks | 
| Change in diastolic blood pressure between 4-8 weeks of treatment. |  | 4-weeks | 
| Change in sistolic blood pressure between 4-8 weeks of treatment. |  | 8-weeks | 
| Treatment response rates | Target blood pressure values were determined by decreasing more than 20mmHg in systolic blood pressure and / or decreasing more than 10mmHg in diastolic pressure (under systolic 140 mmHg, below diastolic 90 mmHg). | 4-weeks |