An Open-label Extension of a Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate Simvastatin 20 mg Plus Omacor 4g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 主要终点
- Median % Change in Non-HDL-C From Baseline to Week 6
研究概览
简要总结
The primary objective of this trial is to assess the continued efficacy of Omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HCL-C) levels.
详细描述
The present trial is an open-label, uncontrolled extension to the previous trial (PRV-06009) which utilized a randomized,double-blind, two-period crossover design with eight clinic visits.
The current trial consists of nine clinic visits over 104 weeks. There will be two treatment periods in this study:
- Phase I: All subjects will receive simvastatin 80 md/d plus Omacor 4 g/d for the first six weeks of the trial.
- Phase II: All subjects will receive simvastatin (at a dose to be determined at the discretion of the Investigator) plus Omacor 4 g/d for the remainder of the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must have met all relevant inclusion/exclusion criteria prior to and throughout the previous double-blind study (PRV-06009)
- •Must have completed the previous double-blind study to week
- •Provide written informed consent and authorization for protected health information
排除标准
- •Study drug compliance less than 50% in PRV-06009
- •Any ongoing serious adverse event from PRV-06009
研究组 & 干预措施
Omacor 4 grams/day plus simvastatin 80 mg/day.
Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
干预措施: Omacor + simvastatin (Drug)
结局指标
主要结局
Median % Change in Non-HDL-C From Baseline to Week 6
时间窗: Week 6
The primary efficacy endpoint will be the median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to Week 6 of PRV-06009X. Briefly, non-HDL-C was measured at Weeks -2, -1, and 0 from blood samples, and the concentrations of non-HDL-C in the blood at these timepoints were averaged to obtain baseline non-HDL-C concentration. Similarly, non-HDLC was measured at Week 6 from blood samples. Statistical analysis was performed comparing the change in non-HDL-C concentration from baseline to Week 6 and presented herein.
次要结局
- Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin(52 weeks)
- Median % Change in Non-HDL-C From Baseline to Week 104(104 weeks)
研究者
Kevin C. Maki, PhD
Study Director/Chief Science Officer
Provident Clinical Research