An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Change in non-high-density lipoprotein cholesterol (non-HDL-C)
研究概览
简要总结
The primary objective of this study is to compare the effect of simvastatin plus Omacor to simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects with mixed dyslipidemia.
详细描述
This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 4 (Week 0), after a 5-week diet lead-in/baseline period, subjects meeting all entry criteria will be randomized to one of two double-blind treatment sequences, simvastatin/Omacor first or simvastatin/placebo first. Each treatment period consists of 6 weeks. After randomization, subjects will self-administer the study drugs once a day in the evening.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, ages 18-79 inclusive
- •Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C level above ATP III goals
- •Fasting, untreated triglyceride (TG) level in the high to very high range
- •Provide written informed consent and authorization for protected health information
排除标准
- •Pregnancy
- •Use of lipid-altering drugs which cannot be stopped
- •History of certain cardiovascular conditions or cardiac surgery within the prior 6 months
- •Body mass index above 40 kg per square meter
- •Allergy or sensitivity to omega-3 fatty acids or to statin drugs
- •Poorly-controlled conditions including diabetes, hypertension, or thyroid disease
- •Certain muscle, liver, kidney, lung or gastrointestinal conditions
- •Certain medications
- •Active cancers treated within prior 2 years (except non-melanoma skin cancer)
研究组 & 干预措施
Simva+Omacor
干预措施: Omacor (omega-3-acid ethyl esters)plus simvastatin (Drug)
Simva + Placebo
干预措施: simvastatin plus placebo (Drug)
结局指标
主要结局
Change in non-high-density lipoprotein cholesterol (non-HDL-C)
时间窗: Baseline to end of treatment
次要结局
- Changes in other lipid and biomarker levels(Baseline through end of treatment)