Azilsartan Circadian and Sleep Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Azilsartan Circadian and Sleep Pressure - the 1st Study

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Azilsartan
* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grade I or II essential hypertension The sitting systolic blood pressure is in term of 140-179 mmHg, or sitting diastolic blood pressure is in term of 90-109 mmHg at the both two time points at the beginning of the observation period and at the beginning of a treatment period (Week0) 20 years old or older at the time of the informed consent Able to give written informed consent before participating in the research Therapeutic category during the observation period: Ambulatory Exclusion Criteria: Secondary hypertension, grade III hypertension (sitting systolic blood pressure greater than or equal to 180 mmHg or sitting diastolic blood pressure greater than or equal to 110 mmHg), malignant hypertension More than 2 kinds of antihypertensive agents for treatment on the hypertension History of taking following medicines within 2 weeks before start of the observation period. When subject with taking any of the following medicine at the time of informed consent is included, stop to take the medicine for determined period after the informed consent. I. Antihypertensive agents II. Antianginal agents III. Antiarrhythmic agents (except single time use of the lidocaine hydrochloride formulation for anesthesia) IV. Digitalis products Less than 130 mmHg of mean 24-hour systolic blood pressure and less than 80 mmHg of mean 24-hour diastolic blood pressure at the start of the observation period. History of following circulatory-related diseases or symptoms within 24 weeks before start of the observation period. I. Cardiac disease: Myocardial infarction, coronary artery revascularization II. Cerebrovascular-disease: cerebral infarction, cerebral hemorrhage, transient ischemic attack III. Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema History or complication with the following circulatory-related diseases; Valvular stenosis, atrial fibrillation, pharmacotherapy-required angina, congestion heart failure, or cardiac arrhythmia, or arteriosclerosis obliterans with symptoms of intermittent claudication et al Day / night reversal History of hypersensitivity or allergy to Azilsartan, Amlodipine, or related drugs Participant in any other clinical research Pregnant, possible to being pregnant, or lactating woman Mal-control of blood pressure during informed consent to taking antihypertensive agent Any those the investigator or other researchers consider as unsuitable

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azilsartan<br>Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks | Drug: Azilsartan<br>* Azilsartan 20mg/day<br>* Other names: AZILVA Tablets;|
| Active Comparator: Amlodipine<br>Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks | Drug: Amlodipine<br>* Amlodipine 5mg/day<br>* Other names: Amlodin Tablets etc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nocturnal Systolic Blood Pressure Level | Change at the end of a treatment period (Week 8) from the beginning point of an observation period *Nocturnal systolic blood pressure level: the mean value of systolic arterial pressure during night (during sleeping) | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) *The targeted value has been set as the median of the dipping rate, normal type of nocturnal blood pressure variation, rate of nocturnal blood pressure fall (10-20 percent) ** Rate of nocturnal blood pressure fall: calculated as (awake SBP-sleep SBP)/awake SBP | Baseline and 8 weeks | 
| Change in Nocturnal Diastolic Blood Pressure Level | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) | Baseline and 8 weeks | 
| Change in 24-hour Mean Systolic Blood Pressure Level | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) | Baseline and 8 weeks | 
| Change in 24-hour Mean Diastolic Blood Pressure Level | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension