JPRN-UMIN000007718已完成2 期
Anti-platelet therapy for prevention of diabetic nephropathy - ATP-D
ational Hospital Organization Headquarters0 个研究点目标入组 150 人开始时间: 2012年4月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) The patient who has hypersensitivity to cilostazol. 2) Contraindication of cilostazol (patients with bleeding and congestive heart failure). 3) The patient administrated cilostazol previously (since possibility to have an influence on the efficacy and the safety). 4) The patient administrated dipyridamole at informed consent and has difficulty for interruption. 5) Tachycardia (heart rate > 100/min) in ECG at visit 2. 6) Severe liver dysfunction (more than 3 times of the standard value upper limit of AST, ALT, -GTP) an visit 2 7) Hb < 9g/dl at visit 2. 8) Pregnant or pregnantpossibility. 9) The patient who has malignancy or previous history of malignancy (however, patient, who is unnecessary of treatment, no recurrence, and become no recurrence during trial, can participate) 10) The patient who has previous history of bleeding, was under treatment of bleeding, or has active diabetic retinopathy. 11) The patient who has the following diseases at Visit2. Chronic urinary tract infection Neurogenic bladder Nephritis or suspect Renal disease excepting diabetic nephropathy (chronic glomerulonephritis, polycystic kidney disease, etc.) 12) The patient administrated CYP3A4 inhibitors (macrolide antibiotic, HIV protease inhibitor, azole antifungals, cimetidine, Diltiazem hydrochloride, etc) (since the pharmacodynamics of cilostazole in vivo will affect the evaluation of dose-reaction relationship) 13) The patient who had participated trials of other unrecognized pharmaceutical products or medical device in the past 30 days. 14) The patient judged to be inadequacy by the attending physician.
研究者
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