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

• Status: Not yet recruiting
• Trial end date: 2022-12-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neutec Ar-Ge San ve Tic A.Ş
• Treatments: Metoprolol

Criteria

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.