Clinical trial NCT04457323: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Neutec Ar-Ge San ve Tic A.Ş
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in systolic and diastolic blood pressure between 0-4 weeks of treatment
timeFrame: 4-weeks
Secondary outcomes:
measure: Change in systolic blood pressure between 0-8 weeks of treatment.
timeFrame: 8-weeks
measure: Change in diastolic blood pressure between 0-8 weeks of treatment.
timeFrame: 8-weeks
measure: Change in diastolic blood pressure between 4-8 weeks of treatment.
timeFrame: 4-weeks
measure: Change in sistolic blood pressure between 4-8 weeks of treatment.
timeFrame: 8-weeks
measure: Treatment response rates
timeFrame: 4-weeks
Other outcomes:
Locations:
Study officials:
References: