NCT01172431已完成4 期
A Comparison of Indapamide SR 1.5 mg With Hydrochlorothiazide 25 mg, in Combination With an ACE-inhibitor, in Old Patients With Mild to Moderate Renal Insufficiency and Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- renal function
研究概览
简要总结
The purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal function, endothelial function, blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Creatinine clearance 30 to 90 mL/min/1.73 m2, with variations of less than 20 percent in the 2 weeks before the screening evaluation.
- •Diagnosed hypertension according to guidelines or having taken anti-hypertension drugs.
- •Aged between 65 and 85 years.
- •Willingness to provide written, informed consent.
- •Ability to adhere to study protocol.
排除标准
- •Secondary hypertension.
- •Diabetes mellitus.
- •Atrial flutter/atrial fibrillation.
- •Symptoms of congestive heart failure (NYHA III-IV) or there is evidence that left ventricular EF < 40%.
- •Recent (< 6 months) myocardial infarction or cerebrovascular ischemic symptoms.
- •Recent (< 3 months) or planned coronary revascularization: PCI (percutaneous coronary intervention)/CABG (coronary artery by-pass graft).
- •Severe valvular heart disease.
- •History of hypersensitivity to indapamide, thiazides or to any of the components of the products.
- •Any current condition or other disease known to interfere significantly with the absorption, distribution, metabolism or excretion of study drugs.
- •Participation to another investigational study in the last 3 months.
研究组 & 干预措施
Indapamide
Experimental
Indapamide SR 1.5mg qd
干预措施: Indapamide (Drug)
Hydrochlorothiazide
Active Comparator
Hydrochlorothiazide 25mg qd
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
renal function
时间窗: 1 year
Effects of indapamide SR 1.5 mg on renal function by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.
次要结局
- endothelial function(1 year)
- blood pressure variability(1 year)
研究者
Xiaoping Chen
Xiaoping Chen, professor, West China Hospital of Sichuan University.
West China Hospital
研究点 (1)
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