title: Rationale, study design, and implementation of the ACS1 study: effect of azilsartan on circadian and sleep blood pressure as compared with amlodipine.
abstract: 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.
  
  
  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).
  
  
  CONCLUSIONS
  The findings of this study will help in establishing an appropriate antihypertensive treatment for hypertensive patients with a disrupted circadian BP rhythm.
authors.affiliation: aDivision of Cardiovascular Medicine, Department of Medicine bDepartment of Sleep and Circadian Cardiology, Jichi Medical University School of Medicine, Tochigi, Japan.
authors.forename: Kazuomi
authors.initials: K
authors.lastname: Kario
authors.forename: Satoshi
authors.initials: S
authors.lastname: Hoshide
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001562:Benzimidazoles / Q000008:administration & dosage*; D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D002940:Circadian Rhythm / Q000187:drug effects*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D010069:Oxadiazoles / Q000008:administration & dosage*; D012890:Sleep / Q000187:drug effects*
chemical_list: D001562:Benzimidazoles; D010069:Oxadiazoles; C521273:azilsartan