Azilsartan Circadian and Sleep Pressure - the 1st Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 957
- 试验地点
- 92
- 主要终点
- Change in Nocturnal Systolic Blood Pressure Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Azilsartan
Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks
干预措施: Azilsartan (Drug)
Amlodipine
Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
干预措施: Amlodipine (Drug)
结局指标
主要结局
Change in Nocturnal Systolic Blood Pressure Level
时间窗: Baseline and 8 weeks
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)
次要结局
- Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall**(Baseline and 8 weeks)
- Change in Nocturnal Diastolic Blood Pressure Level(Baseline and 8 weeks)
- Change in 24-hour Mean Systolic Blood Pressure Level(Baseline and 8 weeks)
- Change in 24-hour Mean Diastolic Blood Pressure Level(Baseline and 8 weeks)