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Patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension ( HTN) was randomized to receive either Valsartan 80 mg/Amlodipine 5 mg fix dose combination (FDC) or a free equivalent combination. Ambulatory blood pressure monitoring at baseline and 8 weeks post-treatment initiation was performed.
Patients were eligible for enrollment if they were between 35 and 70 years old and diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 80 mmHg), and required the initiation of antihypertensive medications.
This study used the permutation block randomization method (block size = 4) for the randomization process.Patients were randomly assigned to either the FDC group or the free equivalent combination group.
Eligible patients underwent an 8-week period during which they received either Valsartan 80 mg and Amlodipine 5 mg as an FDC or as free equivalent combinations. The FDC group received one single tablet daily, while the free combination group received the medications on separate tablets (amlodipine daily and Valsartan in the evening). 24-hour ambulatory blood pressure monitoring (ABPM) at the time of inclusion and at the end of the 8-week period were performed using a standard ABPM device that the patients wore with an appropriately sized cuff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| valsartan- Amlodipine fix dose combination pill | Experimental | Patients with hypertension eligible receiving valsartan- Amlodipine 80/5 mg fix dose combination (FDC) pill |
|
| Valsartan- Amlodipine free dose combination | Active Comparator | Patients with hypertension eligible receiving valsartan 80 mg and amlodipine 5 mg as free dose of drugs separately |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan-amlodipine 80/5 mg FDC | Drug | fix dose combination of valsartan 80 mg and Amlodipine 5 mg given as single pill |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24 hours systolic blood pressure | The average systolic blood pressure over 24 hours, during the day and at night | 8 weeks |
| Mean 24 hours diastolic blood pressure | The average diastolic blood pressure over 24 hours, during the day and at night | 8 weeks |
| Mean 24 hours mean blood pressure | The average mean blood pressure over 24 hours, during the day and at night | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dipping | Drop of Mean systolic pressure more than 10% during nights compare to mean systolic pressure at days | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiraz University of Medical Sciences | Shiraz | Fars | 713481433 | Iran |
The data is available based on rational request
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068838 | Amlodipine, Valsartan Drug Combination |
| D000068756 | Valsartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| valsartan 80 mg and amlodipine 5 mg as free combination | Drug | Free combination of valsartan 80 mg and amlodipine 5 mg given separately |
|
|
| 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 |