A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-536 in Subjects With Mild to Moderate Uncomplicated Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 926
- 主要终点
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 12).
研究概览
简要总结
The purpose of this study was to evaluate the dose-response relationships of azilsartan, once daily (QD) in participants with mild to moderate uncomplicated essential hypertension.
详细描述
Hypertension is known to cause multiple organ damage by being combined with not only blood pressure but also other hemodynamics, endocrinological/metabolic abnormalities and genetic factors. This becomes a medically and medical-economically significant problem in Japan The significance of early treatment of hypertension and of long-term control of blood pressure has been increasing year by year.
Takeda Pharmaceutical Company Limited invented TAK-536 (azilsartan), an angiotensin II receptor blocker for decreasing blood pressure. This study investigating the efficacy and safety of azilsartan using candesartan cilexetil, a widely used antihypertensive drug, as a reference control.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Has mild to moderate uncomplicated essential hypertension.
- •Has a sitting diastolic blood pressure between 95 and <110 mmHg and sitting systolic blood pressure between 150 and <180 mmHg at placebo run-in period (Week -2) or randomization visit.
排除标准
- •Has a cardiovascular disease or symptoms
- •Has been treated with more than 3 different antihypertensives within 27 days prior to placebo run-in period.
- •Has a significant hepatic disorder, hyperkalemia, malignant tumor or significant renal impairment.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Azilsartan 5 mg QD
干预措施: Azilsartan (Drug)
Azilsartan 10 mg QD
干预措施: Azilsartan (Drug)
Azilsartan 20 mg QD
干预措施: Azilsartan (Drug)
Azilsartan 40 mg QD
干预措施: Azilsartan (Drug)
Azilsartan 80 mg QD
干预措施: Azilsartan (Drug)
Candesartan Cilexetil 8 mg titrated to12 mg QD
干预措施: Candesartan cilexetil (Drug)
结局指标
主要结局
Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 12).
时间窗: Baseline and Week 12.
The change between sitting trough clinic diastolic blood pressure measured at week 12 or final visit from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
次要结局
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 2).(Baseline and Week 2.)
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 4).(Baseline and Week 4.)
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 6).(Baseline and Week 6.)
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 8).(Baseline and Week 8.)
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 10).(Baseline and Week 10.)
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 2).(Baseline and Week 2.)
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 4).(Baseline and Week 4.)
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 6).(Baseline and Week 6.)
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 8).(Baseline and Week 8.)
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 10).(Baseline and Week 10.)
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 12).(Baseline and Week 12.)
- Number of Participants with a ≥20 mmHg Decrease in Sitting Trough Systolic Blood Pressure and a ≥10 mmHg Decrease in Sitting Trough Diastolic Blood Pressure.(Baseline and Week 12.)
- Number of Participants with a Sitting Trough Systolic Blood Pressure of <130 mmHg and a Sitting Trough Diastolic Blood Pressure of <85 mmHg.(Baseline and Week 12.)
- Incidence of Adverse Events.(On occurrence (up to Week 12).)
- Change from Baseline in Supine Systolic Blood Pressure.(Baseline and Week 12.)
- Change from Baseline in Supine Diastolic Blood Pressure.(Baseline and Week 12.)
- Change from Baseline in Standing Systolic Blood Pressure.(Baseline and Week 12.)
- Change from Baseline in Standing Diastolic Blood Pressure.(Baseline and Week 12.)
- Change from Baseline in Sitting Pulse Rate.(Baseline and Week 12.)
- Change from Baseline in Weight.(Baseline and Week 12.)
- Change from Baseline in Resting 12-lead Electrocardiogram.(Baseline and Week 12.)
- Number of Participants with a Markedly Abnormal Blood Urea Nitrogen Clinical Laboratory Value.(Baseline and Week 12.)
- Number of Participants with a Markedly Abnormal Uric Acid Clinical Laboratory Value.(Baseline and Week 12.)
- Number of Participants with a Markedly Abnormal Creatinine Clinical Laboratory Value.(Baseline and Week 12.)
- Number of Participants with a Markedly Abnormal Creatine Kinase Clinical Laboratory Value.(Baseline and Week 12.)