NCT00823849已完成4 期
A Randomized, Control,open Label, Multicentre Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker
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
- 200
- 试验地点
- 1
- 主要终点
- Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment.
研究概览
简要总结
- To evaluate the efficacy of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker
- To evaluate the safety of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker
详细描述
Efficacy evaluation:
Primary efficacy index:
After 12 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information
Secondary efficacy index:
After 8 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information
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
- •40~75-year-old male or female
- •Clarified diagnosis of type 2 diabetes mellitus
- •Arteriosclerosis obliterans (ASO) is diagnosed (ASO diagnoses should meet at least one of the conditions as below:
- •ABI<1.0;
- •The pulse of popliteal artery or dorsalis pedis artery is weeken significantly or is different between left and right sides
- •Intermittent claudication, diagnosed as ASO by doctor
- •Ultrasonogram showed that there was atherosclerotic plaque in lower limb within 1 year
- •Informed Consent Form Signature
排除标准
- •Has an allergic history to study drugs
- •Use one of the following drugs: other antiplatelet or anticoagulation agents except Aspirin, other hypolipidemic agents except Statins
- •Type 1 diabetes mellitus, specific diabetes mellitus, or gestational diabetes mellitus
- •Has severe ASO above Fontaine IIb,
- •Hemorrhagic tendency or hemorrhagic disease (such as gastrointestinal tract hemorrhage, etc.)
- •Had a myocardial infarction, angina pectoris, or cerebral infarction within the last 3 months
- •Congestive heart failure
- •Is pregnant, or potentially pregnant, or breastfeeding
- •Severe hepatic insufficient or severe renal insufficiency (AST or ALT is 2.5 times higher than the upper limit of the normal value range, or serum creatinine is 1.2 times higher than the upper limit of the normal value range)
- •Persistent or hardly controlled hypertension (such as malignant hypertension, BP> 160/100 mmHg)
- •Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions)
- •Has a medical history that includes a cardiac syncope or a primary syncope
- •Has conditions that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.)
- •Has severe complications (such as diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.)
- •Other conditions that would exclude the subject from this study by doctor's judgement
研究组 & 干预措施
1
Experimental
干预措施: Cilostazol (Drug)
2
Experimental
干预措施: Probucol (Drug)
3
Experimental
干预措施: Cilostazol+Probucol (Drug)
4
Other
Control Group, regular treatment
干预措施: Control Group (Other)
结局指标
主要结局
Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment.
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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