Evaluation of the Effects of Simvastatin 40 Mg on Lipid Profiles and Specified Circulatory Parameters in Normotensive Hypercholesterolemia Patients(MK-0733-265)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Total cholesterol, ldl-c, hdl-c, and triglycerides
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.
详细描述
This is an open-label, prospective study to investigate lipid-lowering efficacy and sympathetic response of normotensive hypercholesterolemia patients after receiving simvastatin 40 mg once daily for 3 months.
The total duration of the study will be approximately 13 weeks, comprising of a 1-week (or 4 weeks?) screening period and a 12-week active treatment period. 20 hypercholesterolemia patients with normal blood pressure will be enrolled into treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 arrhythmia, unstable angina
- •Hypertension (based on the atp 3 guidelines)
- •Taking potent lipid-lowering agents
- •Unstable diabetes (hba1c >9%) or newly diagnosed (within 3 months), or a change in anti-diabetes medications within 3 months of screening
研究组 & 干预措施
MK0733,simvastatin
20 patients with total cholesterol ≧ 240 mg/dL or LDL-C > 160 mg/dL for primary hypercholesterolemia; LDL-C ≧ 130 mg/dL for secondary hypercholesterolemia with identifiable risk factors will be enrolled into study to receive simvastatin 40 mg once daily for 12 weeks.
干预措施: MK0733 (Drug)
结局指标
主要结局
Total cholesterol, ldl-c, hdl-c, and triglycerides
时间窗: after 12 weeks treatment
次要结局
- Pulse wave velocity(after 12 weeks)
- Baroreflex sensitivity(after 12 weeks treatment)
- Serum nitrite, nitrate and urine c-gmp levels after 12 weeks treatment(after 12 weeks treatment)
研究者
Dong Feng Yeih
Attending Physician of Cardiology
Cardinal Tien Hospital