NCT01922687Unknown4 期
Amlodipine Plus/Minus Atorvastatin for Protection of Arteries
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- flow-mediated dilation (FMD)
研究概览
简要总结
The primary objective of this study is to test the hypothesis that amlodipine plus atorvastatin given in a single tablet (Caduet), compared with amlodipine alone (Norvasc), has a stronger effect in protection of arterial structure and function.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women or men, aged from 40 to 75 years;
- •Women with child-bearing potential should apply an adequate non-pharmacological contraceptive technique;
- •Untreated patients or those on a single antihypertensive drug (except calcium channel blocker ) but with an uncontrolled blood pressure on conventional measurement, ranging from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic. The conventional blood pressure is the average of 3 consecutive measurements in the sitting position or a single visit.
- •The 24 h ambulatory blood pressure should be at least 130 mm Hg systolic or 80 mm Hg diastolic, or higher;
- •Fasting total cholesterol concentration ranging from 4.14 to 6.22 mmol/L (160 to 240 mg/dL);
- •Endothelium-dependent flow-mediated dilatation (FMD) below 10%;
- •Serum activity of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatine kinase (CK) should be within the normal range;
- •Patients should not be on treatment with statins or other lipid-lowering drugs within 3 months of randomization;
- •The patients should sign the informed consent form prior to the participation in the trial at the first visit;
- •Patients should be independent and likely to adhere to the study protocol.
排除标准
- •Secondary hypertension;
- •Low-density lipoprotein cholesterol (LDL-C) below 2.59 mmol/L (100mg/dL);
- •Renal dysfunction defined as eGFR<60ml/min/1.73m2;
- •Current treatment with specific drugs or diets, such as fibrates (especially gemfibrozil), verapamil, amiodarone, grapefruit juice;
- •Excessive alcohol consumption defined as drinking more than 1L/day;
- •Stroke within 2 years of randomization or myocardial infarction occurred previous;
- •Known contra-indications to a dihydropyridine calcium channel blocker or statins;
- •Any life threatening condition;
- •Current participation in another trial or trials.
研究组 & 干预措施
Amlodipine Plus Atorvastatin (Caduet)
Experimental
amlodipine plus atorvastatin in a single tablet (Caduet, Pfizer, USA) was given once daily
干预措施: amlodipine plus atorvastatin (Caduet) (Drug)
Amlodipine (Norvasc)
Active Comparator
amlodipine(Norvasc, Pfizer, USA) given once daily
干预措施: amlodipine (Norvasc) (Drug)
结局指标
主要结局
flow-mediated dilation (FMD)
时间窗: 12-24 weeks
After 12-week maintenance treatment or at 24-week final visit.
次要结局
- pulse wave velocity (cf-PWV, ba-PWV)(12-24 weeks)
- liver function(6-24weeks)
- ankle-brachial index (ABI)(12-24 weeks)
- augmentation index (AIx)(12-24 weeks)
- carotid intima-media thickness (IMT)(12-24 weeks)
- cholesterol level(12-24 weeks)
研究者
Yan Yang
Attending physician
Shanghai Institute of Hypertension
研究点 (1)
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