NCT01252056已完成4 期
A Randomized, Control, Parallel, Open Label, Multi-centre Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol in Combination on Patients With Diabetic Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 1
- 主要终点
- nephropathy development
研究概览
简要总结
The efficacy and safety of Cilostazol and Probucol in combination on patients with diabetic nephropathy is better than the single use.
详细描述
The objectives of this study is:
- To evaluate the efficacy of Probucol on deferring nephropathy development of the patients with diabetic nephropathy (including: the change value of urine albumin from the baseline, the rate of the patients with serum creatinine reaching a doubling of the base-line serum creatinine, the rate of the hemodialysis-free survival).
- To evaluate the efficacy of Cliostazol and Probucol in combination on deferring nephropathy development of the patients with diabetic nephropathy
- To evaluate the efficacy of Cilostazol and Probucol in combination on atherosclerosis related biomarkers change. Atherosclerosis related biomarkers include:(a)Endothelium parameter: ICAM-1, vWF, VCAM-1,and McP-1. (b)Finolysis parameter: TM. (c)Inflammation parameter: Hs-CRP; IL-6. (d)Oxidation parameter: Ox-LDL, 8-OHdG. (e)Lipid parameter: TC, LDL-C, HDL-C, TG.
- To evaluate the efficacy of Cilostazol and Probucol in combination on the progress of carotid intima-media thickness (IMT) on patients with diabetic nephropathy.
- To evaluate the safety of Cilostazol and Probucol in combination on the patients with diabetic nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 40~75 years old
- •Type 2 diabetes mellitus above 6 months
- •HbA1c ≤8%
- •Twice (above 2-week interval) confirmed urinary albumin at 30-3000µg/mg.cre
- •Receive routine dosage ACEI or ARB treatment above 2 months, and the dosage has been fixed for at least 1 month
- •LDL-C>100 mg/dL (2.60 mmol/L) and/ or hyperlipidemia patients with Statins treatment
- •Free will to sign the informed consent form
排除标准
- •Has an allergic history to investigational drugs
- •Receive antilipemic agents (except Statins) within the latest 2 months, including Probucol
- •Receive antiplatelet or anticoagulation agents (except Aspirin) within the latest 2 months, including Cilostazol
- •Rapid progression of nephropathy within the latest 3 months
- •Kidney disease caused by other reasons according to medical history
- •Serum potassium level less than 3.5 mEq/L or more than 5.5 mEq/L
- •Hemorrhagic tendency or hemorrhagic disease (such as alimentary tract hemorrhage, active fundus hemorrhage, etc.)
- •Has a myocardial infarction, angina pectoris, or cerebral infarction within the latest 3 months
- •Congestive heart failure
- •Pregnant, potentially pregnant, or lactating woman
- •Severe hepatic inadequacy (AST or ALT is 2.5 times higher than the upper limit of the normal value range)
- •Serum creatinine level is 1.5 times higher than the upper limit of the normal value range
- •Persistent or hardly controlled hypertension (such as malignant hypertension, SBP≥170 mmHg and/ or DBP≥100 mmHg)
- •Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions)
- •Has a medical history of cardiac syncope or primary syncope
- •Has condition that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.), or for man QT interval>450msec, for woman QT interval>470msec
- •Has severe complication (such as diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.)
- •Register other clinical trials within the latest 3 months
- •Other conditions that would be excluded from this study according to doctors'judgment
研究组 & 干预措施
Probucol
Active Comparator
Probucol treatment
干预措施: Probucol (Drug)
Combination
Active Comparator
Probucol and Cilostazol
干预措施: Probucol and Cilostazol (Drug)
结局指标
主要结局
nephropathy development
时间窗: 96W
After 96-week treatment, compare the efficacy between Probucol group and group control group on deferring nephropathy development of the patients with diabetic nephropathy (including: the change value of urine albumin from the baseline, the rate of the patients with serum creatinine reaching a doubling of the base-line serum creatinine, the rate of the hemodialysis-free survival)
次要结局
- IMT(48 and 96W)
- Atherosclerosis related biomarkers(48 and 96W)
- Nephropathy development(48 and 96W)
- Adverse events(96W)
研究者
研究点 (1)
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