EUCTR2006-000569-13-DE进行中（未招募）不适用
Influence on the coronary Microcirculation and on myocArdial perfusion Reserve of Niaspan given IN addition to simvastatin in diabEtic patients - MARINE
Cardioangiologisches Centrum Bethanien0 个研究点目标入组 40 人开始时间: 2006年8月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •· Age > 18 years
- •· Male or post-menopausal female patients (no HRT)
- •· Diabetes mellitus type 2, controlled by metformin and/or sulphonylurea
- •· HDL <50mg/dl
- •· LDL < 160mg/dl
- •· TG < 400mg/dl
- •· BMI < 30
- •· HbA1c < 8%
- •· Normal renal function (creatinine <0.015g/l
- •· Normal liver blood tests (AST, ALT <1.5x ULN)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •· Prior myocardial infarction, PTCA or CABG
- •· Severe stenosis that needs intervention
- •· Secondary causes of hyperlipidemia (except type 2 diabetes)
- •· Cutaneous and/or tendinous xanthoma
- •· Non-controlled hypertension (SBP > 160 and/or DBP>90 mm Hg)
- •· Use of non-selective beta blockers (propanolol)
- •· Past or current peptic ulcers
- •· Insulin treatment
- •· Regular use of corticosteroids
- •· Drugs able to modify oxidation parameters (probucol, vitamin E, vitamin C)
- •· Daily alcohol consumption > 40g
研究者
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