NCT01211847已完成2 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects Without Diabetes Mellitus Having Very High Fasting Triglyceride Levels, With Double-Blind DCCR-Fenofibrate Combination Extension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Triglyceride-lowering efficacy of DCCR
研究概览
简要总结
Once a day oral administration with DCCR helps lower triglycerides
详细描述
The population will consist of Statin-naive and Statin-treated subjects, all without diabetes mellitus, with fasting triglyceride levels in the range of ≥ 500 mg/dL and < 1500 mg/dL.
Subjects will be randomly assigned to 1 of 2 treatment groups: DCCR and Placebo
Approximately 44 subjects will be enrolled in the study and stratified by Statin use at a 1:1 ratio in each treatment group,
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DCCR
Experimental
DCCR Treatment with 290 mg Diazoxide Choline
干预措施: Diazoxide Choline Controlled-Release Tablet (Drug)
Placebo
Placebo Comparator
Placebo matching DCCR
干预措施: Placebo (Drug)
结局指标
主要结局
Triglyceride-lowering efficacy of DCCR
时间窗: 84 days
Fasting triglycerides (percent change from Baseline to Day 84)
次要结局
- Improvement in other lipid profiles with DCCR(84 days)
研究者
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