EUCTR2004-004226-28-DE进行中（未招募）不适用
Effects of Pioglitazone in Patients with Type 2 Diabetes Mellitus and Coronary Heart Disease at High Risk for Cardiovascular Complications
Takeda Pharma GmbH0 个研究点开始时间: 2005年5月12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
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
- •1. Type 2 Diabetes mellitus
- •2. Angiographically proven CHD (diagnosed within the last 6 months)
- •3. hs CRP > 1 mg/l
- •4. Age 20-80 years
- •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
- •1.Chronic inflammatory diseases (rheumatic diseases, pyelonephritis,
- •osteomyelitis or others.)
- •2.Acute infections
- •3.Treatment or pre-treatment with insulin for more than 6 consecutive days
- •4.Invasive cardiovascular intervention within the last 4 weeks
- •5.Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- •6.History of severe or multiple allergies
- •7.Treatment with any other investigational drug within 3 months before trial entry.
- •8.Progressive fatal disease
- •9.Drug or alcohol abuse within the last 5 years
- •10.A history of symptomatic cardiac insufficiency (NYHA stage II - IV), respiratory, or hepatic insufficiency
- •11.Relevant anaemia (as judged by investigator)
- •12.Blood donation within the last 30 days or intended blood donation (during the study or 30 days after participation?)
- •13.Pregnancy or breast feeding
- •14.Sexually active woman of childbearing age not practicing birth control by using contraceptive medication, condoms or intrauterine devices (IUD).
- •15.Lack of compliance or other similar reason, that, the investigator believes, precludes satisfactory participation in the study
- •16.Pre-treatment with thiazolidinediones
- •17.Systemic glucocorticoid therapy
- •18.Have had more than one unexplained episode of severe hypoglycaemia (defined as requiring assistance of another person due to disabling hypoglycaemia) within 6 month prior to entering the study
研究者
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