Conditions: Hypertension
Keywords: Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 957
Healthy volunteers: no

Brief summary:
To determine the efficacy of Azilsartan 20 mg versus Amlodipine 5 mg oral administration once per day for 8 weeks in patients with grade I or grade II essential hypertension.

Detailed description:
Treatment

\<Run-in period\> Use of any antihypertensives, including azilsartan and amlodipine, is prohibited during the run-in period.

\<Treatment period\> Subjects who are considered eligible for participation in the study based on the results of eligibility assessment during the run-in period will be randomized to the azilsartan 20 mg or amlodipine 5 mg group at a ratio of 1:1 according to the following stratification factors; the type of awake-sleep blood pressure variation determined based on the data from ABPM at the start of run-in, complication status (chronic kidney diseases \[CKD\], type 2 diabetes), age, and sex.

Subjects will start treatment with either antihypertensive after examination for the start of treatment (Week 0) and visit the study site every 2 weeks, 5 visits in total, until the end of treatment (Week 8).

Subjects will orally take azilsartan 20 mg or amlodipine 5 mg, according to their group allocation, once daily before or after breakfast in the morning.

Arms:
arm 1: Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks arm 2: Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks

Interventions: intervention 1: Azilsartan intervention 2: Amlodipine
Intervention descriptions: intervention 1: Azilsartan 20mg/day intervention 2: Amlodipine 5mg/day

Protocol document: