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

Primary Purpose

Hypertension

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Metoprolol
Metoprolol
Sponsored by
Neutec Ar-Ge San ve Tic A.Ş
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Test

    REFERENCE

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Change in systolic and diastolic blood pressure between 0-4 weeks of treatment

    Secondary Outcome Measures

    Change in systolic blood pressure between 0-8 weeks of treatment.
    Change in diastolic blood pressure between 0-8 weeks of treatment.
    Change in diastolic blood pressure between 4-8 weeks of treatment.
    Change in sistolic blood pressure between 4-8 weeks of treatment.
    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).

    Full Information

    First Posted
    June 25, 2020
    Last Updated
    December 9, 2021
    Sponsor
    Neutec Ar-Ge San ve Tic A.Ş
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04457323
    Brief Title
    S-Metoprolol XR 25-50 mg Tablets vs Metoprolol Zok 50-100 mg Tablets in Hypertension Patients.
    Official Title
    Comparison of Efficacy and Safety of S-Metoprolol XR 25-50 mg Tablets and Metoprolol Zok 50-100 mg Tablets in Hypertensive Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2022 (Anticipated)
    Primary Completion Date
    October 15, 2022 (Anticipated)
    Study Completion Date
    December 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Neutec Ar-Ge San ve Tic A.Ş

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    126 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Test
    Arm Type
    Experimental
    Arm Description
    S-Metoprolol XR 25 mg Film Coated Tablets (first four weeks) S-Metoprolol XR 50 mg Film Coated Tablets (second four weeks)
    Arm Title
    REFERENCE
    Arm Type
    Active Comparator
    Arm 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)
    Intervention Type
    Drug
    Intervention Name(s)
    Metoprolol
    Other Intervention Name(s)
    S-metoprolol
    Intervention Description
    S-Metoprolol XR 25 mg and 50 mg Film Coated Tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Metoprolol
    Intervention Description
    Beloc® (Metoprolol) Zok 50 mg and 100 mg Controlled Release Film Tablets
    Primary Outcome Measure Information:
    Title
    Change in systolic and diastolic blood pressure between 0-4 weeks of treatment
    Time Frame
    4-weeks
    Secondary Outcome Measure Information:
    Title
    Change in systolic blood pressure between 0-8 weeks of treatment.
    Time Frame
    8-weeks
    Title
    Change in diastolic blood pressure between 0-8 weeks of treatment.
    Time Frame
    8-weeks
    Title
    Change in diastolic blood pressure between 4-8 weeks of treatment.
    Time Frame
    4-weeks
    Title
    Change in sistolic blood pressure between 4-8 weeks of treatment.
    Time Frame
    8-weeks
    Title
    Treatment response rates
    Description
    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).
    Time Frame
    4-weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Neutec RD
    Phone
    00905051747902
    Email
    iremkaraman@neutecrdc.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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