Hypertension
Conditions
Keywords
hypertension, 24 hours ambulatory blood pressure monitoring, fix dose combination
Brief summary
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.
Detailed description
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.
Interventions
DRUGvalsartan-amlodipine 80/5 mg FDC
fix dose combination of valsartan 80 mg and Amlodipine 5 mg given as single pill
DRUGvalsartan 80 mg and amlodipine 5 mg as free combination
Free combination of valsartan 80 mg and amlodipine 5 mg given separately
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients 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
Exclusion criteria
* Patients previously been on antihypertensive drugs * Patients had secondary high blood pressure * Patients had severe high blood pressure (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg) * Patients had ischemic heart disease in the past * Patients were unable to receive any part of the treatment * Patients who refuse to take part in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24 hours systolic blood pressure | 8 weeks | The average systolic blood pressure over 24 hours, during the day and at night |
| Mean 24 hours diastolic blood pressure | 8 weeks | The average diastolic blood pressure over 24 hours, during the day and at night |
| Mean 24 hours mean blood pressure | 8 weeks | The average mean blood pressure over 24 hours, during the day and at night |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dipping | 8 weeks | Drop of Mean systolic pressure more than 10% during nights compare to mean systolic pressure at days |
Countries
Iran
Outcome results
None listed