NCT02609490已完成3 期
A Multi-center, Randomized, Double-blind, Double-dummy, With Olmesartan Medoxomil as Positive Control Parallel Clinical Study to Evaluate the the Safety and Efficacy of Azilsartan in Chinese Patients With Primary Mild and Moderate Hypertension
Lee's Pharmaceutical Limited1 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Decrease of sitting diastolic blood pressure at week 16
研究概览
简要总结
A phase 3 clinical study to evaluate the safety and efficacy of Azilsartan in Chinese hypertension patients
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
- •18-70 years of age (including 18 and 70 years of age), male or female;
- •diagnosed with mild to moderate essential hypertension;
- •clinic diastolic and systolic blood pressure need to meet the following two conditions: 3 times mean sitting diastolic blood pressure measurements at 95mmHg-110mmHg (not including 110mmHg); 3 times sitting systolic blood pressure measured and mean value between150mmHg-180mmHg (not including 180mmHg);
- •understand clearly that voluntary to participate in the study, sign informed consent.
排除标准
- •severe essential hypertension (sitting systolic ≥180mmHg and / or sitting diastolic pressure ≥110mmHg), malignant hypertension, hypertensive emergency, hypertensive crisis and high blood pressure encephalopathy.
- •secondary hypertension.
- •The following hypertension and diseases: acute myocardial infarction within 6 months, the cerebral artery accident, transient ischemic attack; or dissecting aortic aneurysm, angina, II-IVClass (NYHA classification) history of heart failure Ⅱ degree atrioventricular block, sick sinus integrated disease, bradycardia (heart rate <50 beats / min) or other antiarrhythmic drugs needed.
- •significant laboratory abnormalities include: serum potassium> 5.5mmol / L; blood ALT or AST> 2.5ULN; serum creatinine> 1.5ULN.
- •unilateral or bilateral renal artery stenosis.
- •Type 1 diabetes and poor glycemic control of type 2 diabetes (HbA1c values ≥ 8%).
- •gastrointestinal lesions or gastrointestinal surgery may affect drug absorption or excretion, such as stomach-bowel resection, nearly one year activity of gastrointestinal inflammation, ulcers or gastrointestinal bleeding.
- •azilsartan sheet or olmesartan medoxomil tablets and related drugs (ARB, ACEI And renin inhibitors) allergies.
- •pregnant, lactating female patients, or during the test does not guarantee the effective collision pregnant person.
- •Obesity, body mass index (BMI)> 30kg / m
- •Import of use in addition to import other types of medication trials of antihypertensive drugs, Anti-angina drugs, lithium agents, corticosteroids, licorice, estrogen, digitalis Drugs and drugs were potassium.
- •Variance of diastolic blood pressure ≥8mmHg.
- •drug or alcohol abuse within 6 months Are drinking more than two units of alcohol (1 unit = 360mL or 45mL alcohol content of 40%).
- •14 patients with malignant tumors.
- •hemodialysis patients or strictly limit salt therapy.
- •Participated in other clinical trials within 30 days.
研究组 & 干预措施
Treatment-Azilsartan
Experimental
Azilsartan tabelts
干预措施: Azilsartan tablets (Drug)
Treatment-Azilsartan
Experimental
Azilsartan tabelts
干预措施: olmesartan medoxomil placebo tablets (Drug)
Positive Control-olmesartan medoxomil
Active Comparator
olmesartan medoxomil tablets
干预措施: Azilsartan placebo tablets (Drug)
Positive Control-olmesartan medoxomil
Active Comparator
olmesartan medoxomil tablets
干预措施: Olmesartan medoxomil tablets (Drug)
结局指标
主要结局
Decrease of sitting diastolic blood pressure at week 16
时间窗: 16 weeks
次要结局
- Decrease of sitting systolic blood pressure at week 2(2 weeks)
- Decrease of sitting diastolic blood pressure at week 8(8 weeks)
- Decrease of sitting systolic blood pressure at week 8(8 weeks)
- Decrease of sitting diastolic blood pressure at week 12(12weeks)
- Decrease of sitting systolic blood pressure at week 12(12 weeks)
- Decrease of sitting diastolic blood pressure at week 4(4 weeks)
- Decrease of sitting systolic blood pressure at week 4(4 weeks)
- Decrease of sitting diastolic blood pressure at week 2(2 weeks)
- decrease of 24-hour ambulatory blood pressure monitoring at week 16(16 week)
研究者
研究点 (1)
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