NCT00473655已完成4 期
A Double-blind, Double Dummy, Phase IV, Randomized, Multicenter, Parallel Group, Placebo Controlled Trial to Evaluate the Effect of Rosuvastatin on Triglycerides Levels in Mexican Hypertriglyceridemic Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 334
- 试验地点
- 3
- 主要终点
- Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)
研究概览
简要总结
The primary purpose of this trial is to determine if the treatment with rosuvastatin 10 and 20mg/day during 8 weeks in hypertriglyceridemic patients will reduce their triglyceride levels.
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
- Double
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
- •Patients older than 18 years, both genders, without any previous treatment with statins or other lipid lowering drugs for at least 6 months
- •With elevated triglycerides above 200 and below 800mg/dl and willing to follow all study procedures including assisting to clinics, fasting before blood samples and signing a written consent
排除标准
- •High levels of low-density lipoprotein cholesterol (LDL-C)
- •Unstable cardiovascular condition or awaiting a myocardial revascularization
- •Congestive cardiac failure
- •Uncontrolled diabetes
- •Uncontrolled hypothyroidism
- •Familial hypercholesterolemia
- •Liver/muscle disease
- •Pregnancy
结局指标
主要结局
Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)
时间窗: 8 weeks
Reduction from baseline to end of study
次要结局
- Non-HDL-C Reduction(8 weeks)
- LDL-C Reduction(8 weeks)
- Total Cholesterol Reduction(8 weeks)
- HDL-C Increase(8 weeks)
- ApoA1 Levels(8 weeks)
- hsCRP Reduction(8 weeks)
- Adverse Events Reported(8 weeks)
- ApoB Levels(8 weeks)
研究者
研究点 (3)
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