Vascular Improvement With Olmesartan Medoxomil Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy
研究概览
简要总结
The purpose of this study is to compare in patients with primary hypertension, the non-blood pressure lowering effects of one-year therapy with olmesartan medoxomil vs. those of atenolol on changes in the vascular structure and function.
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
- 否
入选标准
- •Male or female
- •18-75 years of age
- •Mean seated diastolic BP 90-109 or mean seated systolic BP of 140-179
排除标准
- •Secondary hypertension
- •Renal disease
- •Diabetes mellitus
- •Serum creatinine >3.0 mg/dL
- •Hemoglobin <10 mg/dL (males) or <9mg/dL (females)
- •WBC count <2000 cells/mL
- •Platelet count <100,000 cells/mL
- •Either ALT & AST >2.5 x upper limit of normal
- •BMI >35 kg/m2
- •TIA or cerebrovascular attack within 3 months of study entry
研究组 & 干预措施
2
Atenolol tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure
干预措施: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure (Drug)
1
olmesartan medoxomil tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure
干预措施: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure (Drug)
结局指标
主要结局
Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy
时间窗: 52 weeks
次要结局
- Results of vascular function tests(52 weeks)
- Measurement of serum lipid and markers of atherosclerosis(52 weeks)
- Retinal arteriole measurements(52 weeks)
- Calculation of insulin sensitivity measurement(52 weeks)
- 24 hour urine creatinine and thromboxane B2 measurements(12 weeks)
- Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio(52 weeks)