NCT00676845已完成3 期
Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects With Metabolic Syndrome
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company0 个研究点目标入组 133 人开始时间: 2008年8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
- 133
- 主要终点
- The change from baseline in carotid-femoral PWV, after adjustment for change from baseline in mean blood pressure (MBP)as measured at the same visit
研究概览
简要总结
This study will analyse the dose-dependent effect of olmesartan medoxomil on the change in arterial stiffness in subjects with hypertension and metabolic syndrome
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
- Triple (Participant, Care Provider, Investigator)
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 and female outpatients
- •Age greater than or equal to 18 years and less than or equal to 75 years
- •Hypertension and metabolic syndrome defined, according to the ATP III/IDF 2005 and ESH/ESC 2007 definitions, as BP greater than or equal to 130/85 mmHg and <150/95 mmHg (i.e. untreated high normal BP or "low range" mild hypertension) and at least 2 of the following traits at:
- •Abdominal obesity (waist circumference >102 cm for men and >88 cm for women)
- •Triglyceride level greater than or equal to 150 mg/dL
- •High density lipoprotein (HDL) <40 mg/dL for men and <50 mg/dL for women
- •Fasting blood glucose greater than or equal to 110 mg/dL and <126 mg/dL (i.e. no type 2 diabetes)
- •No anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months. Note: treatment with angiotensin II receptor blockers (ARB)or angiotensin-converting enzyme inhibitors (ACE) is not allowed within the last 6 months.
排除标准
- •Pregnant or lactating female (prerequisite for female subjects of childbearing potential: adequate contraception)
- •Type 1 and type 2 diabetes
- •"High range" mild hypertension (i.e. systolic blood pressure [SBP]: 150 - <160 mmHg and /or diastolic blood pressure [DBP]: 95 - <100 mmHg)
- •Moderate (SBP: 160 - 179 mmHg and DBP: 100 - 109 mmHg), severe (SBP: greater than or equal to 180 mmHg and/or greater than or equal to 110 mmHg), or resistant (hypertension resistant to treatment)hypertension
- •Secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
研究组 & 干预措施
1
Placebo Comparator
A 3-week placebo run-in period.
干预措施: placebo (Drug)
2
Experimental
Olmesartan medoxomil oral tablets, at lowest study dosage for 52-week double-blind treatment period
干预措施: olmesartan medoxomil (Drug)
3
Experimental
Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 48 weeks.
干预措施: olmesartan medoxomil (Drug)
4
Experimental
Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 4 weeks followed by the highest study dose for 44 weeks.
干预措施: olmesartan medoxomil (Drug)
结局指标
主要结局
The change from baseline in carotid-femoral PWV, after adjustment for change from baseline in mean blood pressure (MBP)as measured at the same visit
时间窗: Up to 1 year of double-blind treatment
The change from baseline in carotid-femoral pulse wave velocity (PWV)
时间窗: Up to 1 year of double-blind treatment
次要结局
- On common carotid stiffness, intima-media thickness (IMT), and internal diameter(Up to 1 year of double-blind treatment)
- On blood pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM)(Up to 1 year of double-blind treatment)
- On central pulse pressure (PP) and augmentation index (AI)(Up to 1 year of double-blind treatment)
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