NCT01108978终止4 期
Phase IV Study for Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination
研究概览
简要总结
The purpose of this study is to evaluate the Efficacy and Safety of Dehypotin® in the Patients with Type 2 Diabetes Mellitus or Cardiovascular Disease. Eligible patients will be randomly assigned to 1 of 2 arms, either Dehypotin® or placebo, and will receive the diet advisement throughout the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 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 20-75 years
- •Diagnosis of type II Diabetes Mellitus for at least 3 months and/or clinical evident cardiovascular disease (CVD)
- •A hemoglobin A1c concentration has to be < 8% before screening
排除标准
- •Women of child bearing potential who are pregnant, breastfeeding or not using effective contraceptives
- •Known hypersensitivity to Pravastatin or any of its components
- •Have a history of homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia
- •Significant medical illness
- •Known serious conditions, e.g. serum creatine kinase(CK)levels 2.5 times upper limit of normal
- •Subjects being treated with drugs influence serum lipid concentrations
- •Subjects who have cancer or been receiving the cancer chemotherapy
研究组 & 干预措施
Dehypotin
Active Comparator
干预措施: Dehypotin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation absolute and percentage reductions in low-density lipoprotein cholesterol (LDL-C) by fasting biochemistry examination
时间窗: 12-week treatment
次要结局
- Evaluation of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides by fasting biochemistry examination(12-week treatment)
研究者
研究点 (1)
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