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

NCT04457323 | Unknown Phase 4

• 1 other identifier: NEU-03.17
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

  4-weeks

Secondary Outcomes (5)

• 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

  4-weeks

Study Arms (2)

Test

EXPERIMENTAL

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

Drug: Metoprolol

REFERENCE

ACTIVE COMPARATOR

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

Interventions

Metoprolol DRUG

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

Also known as: S-metoprolol

Test

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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,
• nd 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,

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

MeSH Terms

Conditions

Hypertension

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Central Study Contacts

Neutec RD

CONTACT

00905051747902; iremkaraman@neutecrdc.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 7, 2020
• Study Start: January 15, 2022
• Primary Completion: October 15, 2022
• Study Completion: December 15, 2022
• Last Updated: December 10, 2021

Record last verified: 2021-12