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

Neutec Ar-Ge San ve Tic

Status and phase: Unknown; Phase 4

Conditions: Hypertension

Treatments: Drug: Metoprolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT04457323

NEU-03.17

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

Test

Experimental group

Description:

S-Metoprolol XR 25 mg Film Coated Tablets (first four weeks) S-Metoprolol XR 50 mg Film Coated Tablets (second four weeks)

Treatment:

Drug: Metoprolol

Drug: Metoprolol

REFERENCE

Active Comparator group

Description:

Beloc® (Metoprolol) Zok 50 mg Controlled Release Film Tablets (first four weeks) Beloc® (Metoprolol) Zok 100 mg Controlled Release Film Tablets (second four weeks)

Treatment:

Drug: Metoprolol

Drug: Metoprolol