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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: Metoprolol; Drug: Metoprolol

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Neutec RD; Phone Number: 00905051747902; Email: iremkaraman@neutecrdc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2022
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Metoprolol
• Other Study ID Numbers: NEU-03.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No