ACTRN12606000466549已完成4 期
Effect of Nicotinic Acid Prolonged Release on endothelial dysfunction in subjects with Type 2 diabetes mellitus who are receiving optimal dose statin therapy
Professor Gerald Watts0 个研究点目标入组 50 人开始时间: 2006年11月9日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 79 Years（—）
- 性别
- All
入选标准
- •Type 2 diabetes; treatment with HMG-CoA reductase inhibitor (statin) at a stable dose for >=6 weeks; treatment with aspirin therapy (100mg orally daily) for >=2 weeks at screening brachial artery ultrasound; fasting LDL-cholesterol <2.5mmol/L; HDL-cholesterol <=1.5mmol/L, brachial artery FMD <=5.50% on screening ultrasound.
排除标准
- •At screening: daytime insulin treatment (nocte insulin permitted); uncontrolled hyperglycaemia (HbA1c level >8.5%); uncontrolled hypertension (resting BP >150/90mmHg); total fasting cholesterol >=6.0mmol/L or triglycerides >=4.5mmol/L; hypersensitivity to nicotinic acid; hypersensitivity to aspirin therapy; treatment with other lipid-regulating medications (eg. fibrate, ezetimibe, cholestyramine, niacin, fish oil) or with CoQ supplements (within previous 6 weeks); current treatment with warfarin, nitrate or PDE5-inhibitor (eg. sildenafil); history peptic ulcer disease; history of arterial bleeding; recent cardiovascular event (within previous 6 months); atrial fibrillation or other significant dysrhythmia; significantly abnormal renal (creatinine >150ummol/L), liver (ALT >3 times ULN) or thyroid function; Significantly abnormal creatine kinase >3 times ULN; significant anaemia; history of gout; current smoker (previous 6 months); ethanol intake>21 standard drinks/week; significant substance abuse, psychiatric illness or likely poor compliance with study protocol; any other serious illness (eg. cancer) or likelihood of not completing study; technical difficulty with obtaining ultrasound scan of sufficient quality; weight>150kg.
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