A Phase 4 interventional study of valsartan-amlodipine 80/5 mg FDC and valsartan 80 mg and amlodipine 5 mg as free combination in Hypertension, sponsored by Shiraz University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Shiraz University of Medical Sciences · Phase 4, Interventional, and Treatment
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 114 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Exclusion Criteria:
Patients with hypertension eligible receiving valsartan- Amlodipine 80/5 mg fix dose combination (FDC) pill
Drug: valsartan-amlodipine 80/5 mg FDC
Patients with hypertension eligible receiving valsartan 80 mg and amlodipine 5 mg as free dose of drugs separately
Drug: valsartan 80 mg and amlodipine 5 mg as free combination
fix dose combination of valsartan 80 mg and Amlodipine 5 mg given as single pill
Also known as: FDC
Free combination of valsartan 80 mg and amlodipine 5 mg given separately
Also known as: free drug combination
Mean 24 hours systolic blood pressure
The average systolic blood pressure over 24 hours, during the day and at night
Time frame: 8 weeks
Mean 24 hours diastolic blood pressure
The average diastolic blood pressure over 24 hours, during the day and at night
Time frame: 8 weeks
Mean 24 hours mean blood pressure
The average mean blood pressure over 24 hours, during the day and at night
Time frame: 8 weeks
Dipping
Drop of Mean systolic pressure more than 10% during nights compare to mean systolic pressure at days
Time frame: 8 weeks
Plan to share: No — The data is available based on rational request
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Shiraz University of Medical Sciences