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

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04457323
• Other study ID #: NEU-03.17
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 15, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: December 2021
• Source: Neutec Ar-Ge San ve Tic A.S
• Contact: Neutec RD
• Phone: 00905051747902
• Email: iremkaraman[@]neutecrdc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: December 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Metoprolol
S-Metoprolol XR 25 mg and 50 mg Film Coated Tablets
• Metoprolol
Beloc® (Metoprolol) Zok 50 mg and 100 mg Controlled Release Film Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neutec Ar-Ge San ve Tic A.S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic and diastolic blood pressure between 0-4 weeks of treatment		4-weeks
Secondary	Change in systolic blood pressure between 0-8 weeks of treatment.		8-weeks
Secondary	Change in diastolic blood pressure between 0-8 weeks of treatment.		8-weeks
Secondary	Change in diastolic blood pressure between 4-8 weeks of treatment.		4-weeks
Secondary	Change in sistolic blood pressure between 4-8 weeks of treatment.		8-weeks
Secondary	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