EUCTR2008-006937-28-AT进行中（未招募）不适用
Effect of Rosuvastatin on endothelial function in patients with diabetes and glaucoma
niversitätsklinik für Klinische Pharmakologie0 个研究点开始时间: 2008年11月27日最近更新:
相关药物
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
- •- Men and women aged over 18 years
- •- subjects with both hypercholesterolemia and normal lipid profile will be included
- •- Diabetes type I or type II. Only patients with no signs of diabetic retinopathy (level 1) or patients with mild or moderate diabetic retinopathy will be included. Level of diabetic retinopathy will be assessed according to the modified Airlie House classification (1991)
- •- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- •- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •- Normal ophthalmic findings, ametropy < 6 Dpt.
- •-Men and women aged over 18 years
- •- subjects with both hypercholesterolemia and normal lipid profile will be included
- •- Open angle glaucoma defined as pathological optic disc appearance and characteristic visual field loss. Visual field loss is defined as having a glaucoma hemifield test outside normal limits and /or a CPSD with P < 0.05 (Keltner et al. 2003)
- •- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- •- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •- Normal ophthalmic findings, ametropy < 6 Dpt
- •- sufficiently controlled intraocular pressure
- •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
- •-Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- •-Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •-Previous or current treatment with statins
- •-Current treatment with fibrates
- •-History or presence of renal failure, creatine kinase (CK) and lactic dehydrogenase (LDH) above normal levels
- •-History or presence of hepatic dysfunction, including increase of liver enzymes
- •-Patients with known hypersensitivity to the study drug or any ingredients
- •-Patients with or with a history of myopathy
- •-Systemic treatment with oral anticoagulants except low dose aspirin
- •-Blood donation during the previous 3 weeks
- •-Ametropy more than 6 dpt
- •-Presence of intraocular pathology other than non proliferative diabetic retinopathy for cohort I and glaucoma for cohort II
- •-Ophthalmolgical surgery (including argon laser trabeculoplasty (ALT), trabeculectomy, deep sclerectomy) within the last 6 months before the study
- •-History or family history of epilepsy
- •-Pregnancy
研究者
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