A Double-blind, Randomized, Placebo-controlled, Two-period Crossover Trial to Assess the Effects of 4 g/d Prescription Omega-3 Ethyl Esters on Low-density Lipoprotein Cholesterol in Subjects With Primary Hypercholesterolemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in LDL-C During Each Treatment
研究概览
简要总结
The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.
详细描述
This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or P-OM3 for the first 6 week phase followed by the study product they did not receive during the first phase (P-OM3 or placebo) for the second 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 inclusive
- •Fasting, untreated low-density lipoprotein cholesterol (LDL-C)level in the borderline high to very high range
- •Fasting, untreated triglyceride (TG)level in the normal range
- •Provide written informed consent and authorization for protected health information
排除标准
- •CHD or CHD risk equivalent
- •Pregnancy
- •Use of lipid altering medications which cannot be stopped
- •Body mass index over 45 kg per square meter
- •Allergy or sensitivity to omega-3 fatty acids
- •Certain muscle, liver, kidney, lung or gastrointestinal conditions
- •Poorly controlled hypertension
- •Certain medications
- •Active cancers treated within prior 2 years (except non-melanoma skin cancer)
研究组 & 干预措施
P-OM3 then Placebo
P-OM3 (4 g/d) for the first six weeks of treatment. Placebo (soy oil) for the second six weeks of treatment.
干预措施: P-OM3 (Drug)
P-OM3 then Placebo
P-OM3 (4 g/d) for the first six weeks of treatment. Placebo (soy oil) for the second six weeks of treatment.
干预措施: Placebo (Drug)
Placebo then P-OM3
Placebo (soy oil) for the first six weeks of treatment. P-OM3 (4 g/d) for the second six weeks of treatment.
干预措施: P-OM3 (Drug)
Placebo then P-OM3
Placebo (soy oil) for the first six weeks of treatment. P-OM3 (4 g/d) for the second six weeks of treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in LDL-C During Each Treatment
时间窗: Baseline (average of weeks -1 and 0) and after 5 or 6 weeks of intervention (average of weeks 5 and 6 for the first treatment phase; average of weeks 11 and 12 for the second treatment phase).
The primary outcome variable will be the percent change from baseline in LDL-C during each treatment. Baseline will be considered the average of values obtained at weeks -1 and 0. On-treatment values will be the average of values collected at weeks 5 and 6 for phase 1, and the average of values collected at weeks 11 and 12 for phase 2.
次要结局
- Percent Changes in Other Lipid and Biomarker Levels(Baseline (average of weeks -1 and 0) and after 5 or 6 weeks of intervention (average of weeks 5 and 6 for the first treatment phase; average of weeks 11 and 12 for the second treatment phase).)
研究者
Kevin C. Maki, PhD
Study Director/Chief Science Officer
Provident Clinical Research