A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 主要终点
- Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in non-high-density lipoprotein cholesterol
研究概览
简要总结
The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite statin therapy.
Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.
详细描述
Two studies comprise this OM6 Program. Study OM6 / LOV111858 (double-blind study) and is not required to post results based on FDAAA. Study OM6X / LOV111818 (open-label extension) is posted on NCT00903409.
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 (Participant, Investigator)
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 years, inclusive
- •Current therapy with a statin drug
- •Triglyceride levels between 200 and 499 mg/dL
- •Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests
- •Provide written informed consent and authorization for protected health information disclosure
排除标准
- •Sensitivity to statin drugs or omega-3 fatty acids
- •Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia
- •Unexplained muscle pain or weakness
- •History of pancreatitis
- •Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or cancer (except non-melanoma skin cancer)
- •Poorly controlled diabetes, or receiving insulin therapy
- •Pregnant or lactating females. Women of childbearing potential who are not using a medically approved method of contraception.
- •Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs
- •Use of warfarin (Coumadin)
研究组 & 干预措施
Simvastatin
Simvastatin + placebo
干预措施: Simvastatin (Drug)
Simvastatin + Lovaza
Simvastatin + Lovaza (omega-3-acid ethyl esters)
干预措施: Simvastatin + Lovaza (Drug)
结局指标
主要结局
Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in non-high-density lipoprotein cholesterol
时间窗: 8 weeks
次要结局
- OM6/LOV111858 - Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in other lipid and biomarker levels(8 weeks)