NCT00398294已完成4 期
An Open-Label, Single-Arm, Prospective Study to Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet in Patients With Hypercholesterolemia
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Total cholesterol, ldl-c, hdl-c, and triglycerides after 12 weeks
研究概览
简要总结
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient, >18 years of age
- •Patients with hypercholesterolemia who meet the following lipid criteria:
- •primary cholesterolemia: total cholesterol>=240 mg/dl or ldl-c >= 160 mg/dl
- •secondary cholesterolemia (patients with cad, dm): ldl-c>=130 mg/dl
- •The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study
排除标准
- •Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmias, unstable angina pectoris
- •Myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months of visit 1
- •Uncontrolled hypertension with systolic blood pressure > 160 mmhg or diastolic > 100 mmhg at visit
- •Unstable diabetes (hba1c >9%) or newly diagnosed (within 3 months)or change in anti-diabetes medications within 3 months of screening
结局指标
主要结局
Total cholesterol, ldl-c, hdl-c, and triglycerides after 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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