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Randomized comparison of bisoprolol 2.5 mg monotherapy with fix combination drug valsartan 80 mg- amlodipine 5 mg
In this randomized, triple-blind, two-arm clinical trial, 59 adults aged 18-60 years with newly diagnosed stage 1-2 hypertension were assigned to bisoprolol 2.5 mg once daily (n=30) or a valsartan 80 mg + amlodipine 5 mg single-pill combination (n=29) for two months. Blood pressure was assessed using 24-hour ambulatory monitoring at baseline and after treatment. Statistical analysis included paired t-tests, ANOVA, and nonparametric methods, with significance set at p<0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bisoprolol | Active Comparator | Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet bisoprolol |
|
| Valsartan- Amlodipine fix dose combination | Active Comparator | Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet valsartan-Amlodipine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisoprolol | Drug | Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet bisoprolol |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean blood pressure | mean blood pressure derived from 24 hours holter monitoring | 2 months |
| mean blood pressure nighttime | mean blood pressure at nighttime derived from 24 hours holter monitoring | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| drug adverse effect | any drug adverse effect reported by patient | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| professor Kojuri cardiology clinic | Shiraz | Fars | 55318 | Iran |
Data will be available with rational request
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| D000068838 | Amlodipine, Valsartan Drug Combination |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| valsartan and amlodipine | Drug | Newly diagnosed hypertensives, proved by 24 hours holter monitoring, receiving tablet valsartan-amlodipine fix combination pill |
|
|
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D000068756 | Valsartan |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017311 | Amlodipine |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |