NCT02407210Unknown3 期
A Phase 3, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Azilsartan Compared to Olmesartan Medoxomil in Chinese Participants With Grade I or II Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Trough sitting diastolic blood pressure (change from end of the run-in period to end of the treatment period)
研究概览
简要总结
To investigate the efficacy and safety of azilsartan compared to olmesartan medoxomil in patients with grade I or II essential hypertension
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes. eighteen years or older and no more than 70 years at the time of informed consent
- •Grade I or II essential hypertension
- •Both sitting systolic and diastolic blood pressures at Week 0 during the run-in period meet the following criteria:
- •Sitting systolic blood pressure: greater than or equal to 150 mmHg and less than 180 mmHg
- •Sitting diastolic blood pressure: greater than or equal to 95 mmHg and less than 110 mmHg
- •Able to understand the content of the study and comply with the study and to give informed consent in writing before participating in the study
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), or malignant hypertension，hypertensive emergencies，hypertensive urgencies
- •The following circulatory-related diseases or symptoms:
- •(1) Cardiac disease: angina pectoris; valvular stenosis; atrial fibrillation; the following diseases requiring medication: congestive heart failure or arrhythmia； (2) Cerebrovascular disorder: cerebral infarction, cerebral hemorrhage (onset within 24 weeks before start of the screening period), transient ischemic attack (onset of an attack within 24 weeks before start of the screening period)； (3) Vascular disease: arteriosclerosis obliterans with symptoms of intermittent claudication； (4) Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema (observed within 24 weeks after start of the screening period)
- •Decrease in sitting diastolic blood pressure by 8 mmHg or more at the end of the run-in period (Week 0) compared to the start of the screening period
- •Day/night reversal, e.g., nightshift worker
- •Unilateral or bilateral renal artery stenosis
- •Clinically apparent hepatic and renal impairment (e.g., with AST and ALT values of 2.5 x upper limit of normal or higher, with serum creatinine value of 1.5 x upper limit of normal or higher during the screening period)
- •Hyperkalemia (with a laboratory value of 5.5 mEq/L or higher during the run-in period)
- •Malignant tumor
- •Compliance with the study drug of less than 80% during the run-in period
- •Poorly-controlled diabetes mellitus (fasting plasma glucose greater than 11mmol/L)，and/or complications (kidney disease, peripheral neuropathy) at Screening.
- •History of hypersensitivity or allergy to olmesartan medoxomil tablets and related drugs (ARB, ACE inhibitors, and renin inhibitors)
- •History of drug abuse (defined as illegal drug use) or alcohol dependency within 2 years before start of the screening period
- •Requirement of the excluded treatment
- •Pregnant or lactating women
- •Participation in another clinical trial or post-marketing clinical trial within 30 days before start of the screening period
- •Dangerous machinery operator such as aerial worker，motor vehicle driver
研究组 & 干预措施
azilsartan group
Experimental
Once-daily oral administration of 20 or 40 mg tablet before or after breakfast
干预措施: azilsartan (Drug)
olmesartan medoxomil group
Active Comparator
Once-daily oral administration of 20 or 40 mg tablet before or after breakfast
干预措施: Olmesartan medoxomil (Drug)
结局指标
主要结局
Trough sitting diastolic blood pressure (change from end of the run-in period to end of the treatment period)
时间窗: 16 weeks
次要结局
- Trough sitting diastolic and systolic blood pressure (change from end of the run-in period to Week 8 of the treatment period)(8 weeks)
- Trough sitting diastolic and systolic blood pressures at each evaluation(2 weeks)
- evaluation by ABPM (1: 24-hour mean change in diastolic and systolic blood pressures, 2: Trough/Peak ratio of diastolic and systolic blood pressures)(change from end of the run-in period to Week 14 of the treatment period)(14 weeks)
- Trough sitting systolic blood pressure (change from end of the run-in period to end of the treatment period)(16 weeks)
- responder rate; rate of patients with normalized blood pressure(8 weeks and 16 weeks)
研究者
研究点 (1)
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