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The aim of this study is to compare the efficacy and safety of S-Metoprolol XR 25 and 50 mg Film Coated Tablets and BelocĀ® (Metoprolol) Zok 50 and 100 mg Controlled Release Film Tablets administered once daily, in the treatment of hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | S-Metoprolol XR 25 mg Film Coated Tablets (first four weeks) S-Metoprolol XR 50 mg Film Coated Tablets (second four weeks) |
|
| REFERENCE | Active Comparator | BelocĀ® (Metoprolol) Zok 50 mg Controlled Release Film Tablets (first four weeks) BelocĀ® (Metoprolol) Zok 100 mg Controlled Release Film Tablets (second four weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol | Drug | S-Metoprolol XR 25 mg and 50 mg Film Coated Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic and diastolic blood pressure between 0-4 weeks of treatment | 4-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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,
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neutec RD | Contact | 00905051747902 | iremkaraman@neutecrdc.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Metoprolol | Drug | BelocĀ® (Metoprolol) Zok 50 mg and 100 mg Controlled Release Film Tablets |
|
| 4-weeks |
| Change in sistolic blood pressure between 4-8 weeks of treatment. | 8-weeks |
| 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 |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |