NCT00973115已完成3 期
Efficacy and Safety of Morning Versus Evening Intake of Simvast CR Tablet in Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 3 Trial
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- the percent change from baseline in LDL cholesterol
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of morning versus evening intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL) cholesterol percent change.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 19 and 75
- •Defined as a fasting 100mg/dl≤ LDL cholesterol <220mg/dl and triglyceride level<400 mg/dl
- •Need drug therapy by NCEP ATP III guideline
- •Signed informed consent
排除标准
- •Has a hypersensitivity to HMG-CoA reductase inhibitor or simvastatin
- •Has a presence or history of alcohol abuse or drug abuse
- •Active gallbladder disease within 12 months
- •Pancreatitis or Hepatic dysfunction (ALT or AST levels > 2XUNL)
- •HbA1c≥ 9% in type 2 diabetes mellitus patients
- •SBP < 90mmHg or > 160mmHg
- •DBP < 50mmHg or > 100mmHg
- •Myocardial infarction or revascularization procedure within 6 months
- •Has significant cardiovascular disease
- •Malignant tumor within 5years
- •Has fibromyalgia, myopathy, rhabdomyolysis or acute myalgia
- •Uric acid level > 9 mg/dl
- •Thyroid stimulating hormone ≥ 2XUNL
- •Active peptic ulcer disease
- •CPK levels > 3XUNL
- •creatinine level > 2 mg/dl
- •Negative pregnancy test for women of childbearing age and agreement to use contraception while on study
- •Had participated other clinical trial within 4 weeks
- •Need systemic administration of corticosteroids intermittently
研究组 & 干预措施
Simvastatin CR 20mg- morning administration
Experimental
干预措施: Simvastatin CR (Drug)
Simvastatin CR 20mg- evening administration
Active Comparator
干预措施: Simvastatin CR (Drug)
结局指标
主要结局
the percent change from baseline in LDL cholesterol
时间窗: week 8
次要结局
- the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a)(week 8)
研究者
研究点 (1)
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