JPRN-UMIN000003486已完成未知
Standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy - Standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy (EMPATHY)
Shionogi & Co., Ltd.0 个研究点目标入组 5,000 人开始时间: 2010年4月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 5,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients to whom any of the following criteria apply will be excluded from the study: at interim registration: 1) patients with history of hypersensitivity to statins 2) patients with history of drug-induced muscle disorder 3) patients with history of coronary arterial diseases (MI, angina pectoris, coronary revascularization) 4) patients with history of stroke (including revascularization) 5) patients complicated with symptomatic PAD (Fontaine class II or above) 6) hypertensive patients with diastolic BP of 120 mmHg or more or systolic BP of 200 mmHg or more, or patients with hypertensive emergency 7) patients with NYHA functional class IIM or more 8) patients with cardiac valvulopathy who have serious hemodynamic abnormality 9) patients under treatment with at least 2 different lipid-lowering drugs 10) patients with familial hypercholesterolemia 11) patients with serious complications e.g. malignant tumors or patients with limited life expectancy (however, patients who are decided free of relapse without treatment of malignant tumors over five years before obtaining their informed consent are able to be enrolled) 12) patients with renal transplant or patients under dialysis 13) patients who are pregnant or who are at risk of pregnancy, or those who desire to become pregnant during their participation in the study 14) other patients deemed unsuitable by the principal investigator or investigator. At official registration: The study will be discontinued in patients who have undergone prespecified examinations during the observation period and satisfy any of the following criteria: 1) patients with apparent ischemia in ECG at rest 2) patients with AST of 100 IU/L or above or ALT of 100 IU/L or above 3) patients with serum creatinine of 2.0 mg/dL or more or eGFR of 30 mL/min/1.73 m2 or less 4) patients with nephrotic syndrome 5) patients with serum triglyceride of 1000 mg/dL or more 6) other patients deemed unsuitable by the principal investigator or investigator.
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