NCT00891267已完成3 期
Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company0 个研究点目标入组 60 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- To investigate the anti-inflammatory effect of Olmesartan (OM) higher dose compared to Olmesartan (OM) lower dose and amlodipine (AML) on the change in levels of the inflammatory marker hs-CRP
研究概览
简要总结
The purpose of this study is to study the effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation
- •Blood pressure greater than or equal to 130/85 mmHg AND
- •hs-CRP greater than or equal to 1.0 and less than 10.0 mg/dL AND at least two (2) of the following traits of the metabolic syndrome (ATP III criteria):
- •abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women;
- •triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for men and less than 50 mg/dL for women
- •fasting blood glucose greater than or equal to 110mg/dL
排除标准
- •Insulin depended diabetes or type-1 diabetes
- •Severe or resistant hypertension
- •Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
- •Any acute or chronic inflammatory disease
- •Constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start
- •Pregnant or lactating female patients of childbearing potential (prerequisite: adequate contraception);
- •Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the trial drug(s)
研究组 & 干预措施
Olmesartan medoxomil low dose
Experimental
Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
干预措施: Olmesartan medoxomil tablets low dose (Drug)
Olmesartan medoxomil tablets high dose
Experimental
Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
干预措施: Olmesartan medoxomil tablets high dose (Drug)
Amlodipine
Active Comparator
Amlodipine taken once daily for 6 weeks
干预措施: Amlodipine (Drug)
结局指标
主要结局
To investigate the anti-inflammatory effect of Olmesartan (OM) higher dose compared to Olmesartan (OM) lower dose and amlodipine (AML) on the change in levels of the inflammatory marker hs-CRP
时间窗: 6 weeks for each treatment
次要结局
- To evaluate the additional antihypertensive efficacy in blood pressure (BP) lowering, assessed by conventional BP measurement and 24-h ambulatory BP measurement (24-h ABPM)(6 weeks for each treatment)
研究者
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