Hypertension
Conditions
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.
Interventions
DRUGMetoprolol
S-Metoprolol XR 25 mg and 50 mg Film Coated Tablets
Sponsors
Neutec Ar-Ge San ve Tic A.Ş
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in systolic and diastolic blood pressure between 0-4 weeks of treatment | 4-weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Contacts
Primary ContactNeutec RD
Outcome results
None listed