NCT02373462终止4 期
Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Pain free maximum walking distance and time
研究概览
简要总结
To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 20 and 85 years at visit 1
- •Patients with ankle-brachial index (ABI) of less than 0.9 in one or both legs with history of intermittent claudication stable for the previous 6 months
- •Patients whose statins, anti hypertensive medications and antiplatelet medications are stable for the past 6 months. Statins and cilostazol are allowed but needs to be stable for the past 6 months (diabetic medications may be changed)
- •Patients whose blood pressure is more than 140/90 mmHg with/without anti-hypertension treatment
排除标准
- •Blood pressure of more than 180/110 mmHg
- •Patients taking ARBs or ACE inhibitors treatment for at least 6 months before
- •Patients taking aldosterone receptor antagonists at least 6 months before
- •Patients with serum creatinine of more than 3 mg/dL
- •serum potassium (K+) > 5.5mg/dl
- •History of bilateral renal artery stenosis
- •History of acute coronary syndrome or heart failure hospitalization within 6 months
- •Peripheral arterial revascularization planned within 1 month
- •Critical limb ischemia
- •Patients with impaired cognition (e.g. dementia)
- •pregnancy or women at age of childbearing potential
研究组 & 干预措施
olmesartan group
Experimental
olmesartan (20mg qd then 40mg qd for titrating BP <140/90 mmHg)
干预措施: Olmesartan (Drug)
other group
Active Comparator
other anti-hypertensive drug (titrating BP <140/90 mmHg)
干预措施: other anti-hypertensive drug (Drug)
结局指标
主要结局
Pain free maximum walking distance and time
时间窗: 12th week
Effect of olmesartan in maximum, pain free walking distance \& time
次要结局
- Quality of life as measured by questionnaires(24th week)
研究者
研究点 (1)
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