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

NCT ID: NCT04457323

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2022-12-15

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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test

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

Group Type EXPERIMENTAL

Metoprolol

Intervention Type DRUG

S-Metoprolol XR 25 mg and 50 mg Film Coated Tablets

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)

Group Type ACTIVE_COMPARATOR

Metoprolol

Intervention Type DRUG

Beloc® (Metoprolol) Zok 50 mg and 100 mg Controlled Release Film Tablets

Interventions

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Metoprolol

S-Metoprolol XR 25 mg and 50 mg Film Coated Tablets

Intervention Type DRUG

Metoprolol

Beloc® (Metoprolol) Zok 50 mg and 100 mg Controlled Release Film Tablets

Intervention Type DRUG

Other Intervention Names

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S-metoprolol

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neutec Ar-Ge San ve Tic A.Ş

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Neutec RD

Role: CONTACT

Phone: 00905051747902

Email: [email protected]

Other Identifiers

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NEU-03.17

Identifier Type: -

Identifier Source: org_study_id