Status:
UNKNOWN
S-Metoprolol XR 25-50 mg Tablets vs Metoprolol Zok 50-100 mg Tablets in Hypertension Patients.
Lead Sponsor:
Neutec Ar-Ge San ve Tic A.Ş
Conditions:
Hypertension
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2022
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04457323
Start Date
January 15 2022
End Date
December 15 2022
Last Update
December 10 2021
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