Key result
The ACS1 study is a planned randomized controlled trial designed to compare the efficacy of azilsartan 20 mg versus amlodipine 5 mg in lowering nocturnal systolic blood pressure; no clinical results are reported.
Why the study?
Does azilsartan 20 mg reduce nocturnal systolic blood pressure more effectively than amlodipine 5 mg in patients with stage I or II primary hypertension?
RCT (n=700)
Open-label
Dynamic allocation
Yes
Does azilsartan 20 mg reduce nocturnal systolic blood pressure more effectively than amlodipine 5 mg in patients with stage I or II primary hypertension?
The ACS1 study protocol outlines an investigator-initiated trial to determine whether azilsartan is superior to amlodipine in reducing nocturnal blood pressure and restoring normal circadian blood pressure rhythms in patients with mild-to-moderate hypertension.
OBJECTIVE: The ACS1 (Azilsartan Circadian and Sleep Pressure - the first study) is a multicenter, randomized, open-label, two parallel-group study carried out to investigate the efficacy of an 8-week oral treatment with azilsartan 20 mg in comparison with amlodipine 5 mg. MATERIALS AND METHODS: The patients with stage I or II primary hypertension will be randomly assigned to either an azilsartan group (n=350) or an amlodipine group (n=350). The primary endpoint is a change in nocturnal systolic blood pressure (BP) as measured by ambulatory BP monitoring at the end of follow-up relative to the baseline level during the run-in period. In addition, we will carry out the same analysis after dividing four different nocturnal BP dipping statuses (extreme-dippers, dippers, nondipper, and risers). CONCLUSION: The findings of this study will help in establishing an appropriate antihypertensive treatment for hypertensive patients with a disrupted circadian BP rhythm.
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Kario et al. (2014) conducted an RCT in Stage I or II primary hypertension (n=700). Azilsartan vs. Amlodipine 5 mg once daily was evaluated on Change in the mean nocturnal systolic blood pressure as measured by ABPM at the end of the treatment period (week 8) from baseline. The ACS1 study is a planned randomized controlled trial designed to compare the efficacy of azilsartan 20 mg versus amlodipine 5 mg in lowering nocturnal systolic blood pressure; no clinical results are reported.
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