NCT00185094已完成4 期
The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity
研究概览
简要总结
To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.
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
- •Patients between the ages of 18 and 75 years (inclusive)
- •Willingness to undergo insulin clamp procedure twice
- •Overweight or obese (BMI=25-39 kg/m2)
- •Subject must meet one of the following two blood pressure criteria at week-2 and at week-1: Systolic blood pressure 140-179 mmHg and diastolic blood pressure 85-99 mmHg OR Systolic blood pressure < 140 mmHg and diastolic blood pressure 90-99 mmHg
- •If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study
排除标准
- •Systolic blood pressure > 179 mmHg
- •Diastolic blood pressure > 99 mmHg or < 85 mmHg
- •Diagnosis of diabetes mellitus
- •History of myocardial infraction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, unstable angina pectoris or an episode of heart failure requiring hospitalization
- •Previous history of a cerebrovascular accident or a transient ischemic attack
- •History of allergic response to atenolol, losartan potassium, olmesartan medoxomil or any of their components
- •Any serious disorder, including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases, that would interfere with the conduct of the study or interpretation of the data
- •Laboratory abnormalities that could compromise subject safety
结局指标
主要结局
To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity
次要结局
- -To compare the treatment effect of losartan potassium versus atenolol on insulin sensitivity
- -To compare the treatment effect of olmesartan medoxomil versus losartan potassium on insulin sensitivity
研究者
研究点 (10)
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