Changes in Central Aortic Pressure, Endothelial Function and Biomarkers in African Americans With Cardiometabolic Syndrome: Comparison of Amlodipine/Olmesartan Versus Hydrochlorothiazide/Losartan
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Central Aortic Pressure (CAP)
研究概览
简要总结
The purpose of the study is to compare the effects of Azor (a combination of amlodipine and olmesartan) with Hyzaar ( a combination of losartan and hydrochlorothiazide) on the thin lining on the inside of blood vessels. These cells help keep blood vessels healthy and blood pressure normal.
详细描述
Participants must be 18-75 years of age, African American, and have a combination of high blood pressure, insulin resistance (Type 2 Diabetes), low HDL cholesterol levels or obesity.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •African American
- •Hypertension and one of the following:
- •Fasting glucose > 100 mg/dl
- •HgA1C> 6.0 %
- •Plasma triglycerides >150
- •HDL cholesterol < 40 mg/dl in men or < 50 mg/dl in women
排除标准
- •History of Heart failure
- •use of insulin
- •non-dominant arm circ > 50 cm.
研究组 & 干预措施
Hyzaar-Treatment Arm B
Weeks 1-2: Hyzaar® 50/12.5 Weeks 3-14: Hyzaar® 100/25 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily
干预措施: losartan and HCTZ (Drug)
Azor-Treatment A
Weeks 1-2: Azor® 5/20 Weeks 3-14: Azor® 10/40 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily
干预措施: amlodipine and olmesartan (Drug)
结局指标
主要结局
Change in Central Aortic Pressure (CAP)
时间窗: 14 weeks
The primary efficacy endpoints, defined as the change from baseline of Central Aortic Systolic Pressure (CAP) and the change in brachial artery reactivity (BART) via ultrasound testing, will be compared at the end of 14 weeks of randomized treatment.
次要结局
- Blood pressure control(25 weeks)