A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-491 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
- 449
- 主要终点
- Change From Baseline in Sitting Clinic Diastolic Blood Pressure.
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with hypertension.
详细描述
Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. Data from the Framingham Heart study suggest that the lifetime risk of developing hypertension among 55- to 65-year-old individuals is greater than 90%. According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of hypertension treatments, hypertension remains inadequately controlled; only about one third of patients continue to maintain control successfully. To help address these matters, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure proposes a more aggressive intervention to hypertension management with more potent antihypertensive agents and combination therapy.
Takeda Global Research & Development Center, Inc. is developing TAK-491 (azilsartan medoxomil) to treat mild to moderate essential hypertension. Azilsartan medoxomil is a prodrug that is rapidly hydrolyzed to the activity moiety, azilsartan, which is an angiotensin II type 1 receptor antagonist. This study is proposed to evaluate the efficacy, safety and tolerability of multiple doses of azilsartan medoxomil at five dose levels in subjects with mild to moderate uncomplicated essential hypertension.
Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 11 weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations, electrocardiogram Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at approximately 24 and 36 hour intervals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Azilsartan Medoxomil 5 mg QD
干预措施: Azilsartan Medoxomil (Drug)
Azilsartan Medoxomil 10 mg QD
干预措施: Azilsartan Medoxomil (Drug)
Azilsartan Medoxomil 20 mg QD
干预措施: Azilsartan Medoxomil (Drug)
Azilsartan Medoxomil 40 mg QD
干预措施: Azilsartan Medoxomil (Drug)
Azilsartan Medoxomil 80 mg QD
干预措施: Azilsartan Medoxomil (Drug)
Olmesartan 20 mg QD
干预措施: Olmesartan (Drug)
Placebo QD
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Sitting Clinic Diastolic Blood Pressure.
时间窗: Baseline and Week 8.
The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
次要结局
- Change From Baseline in Sitting Clinic Systolic Blood Pressure.(Baseline and Week 8)
- Change From Baseline in Standing Clinic Systolic Blood Pressure.(Baseline and Week 8.)
- Change From Baseline in Standing Clinic Diastolic Blood Pressure.(Baseline and Week 8.)
- Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8)
- Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)
- Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8)
- Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.(Baseline and Week 8.)