A Multi-Center, Randomized, Double-Blind, Placebo- and Active-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 Active-Controlled Extension Assessing Safety and Tolerability
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days
研究概览
简要总结
The hypothesis of this study is that DCCR is effective as both monotherapy and in combination with a statin in lowering triglycerides in subjects with very high triglycerides
详细描述
Very high triglyceride is a risk for pancreatitis. Studies have shown Diazoxide Choline has the potential to effectively lower triglycerides in patients with very high triglycerides.
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
- Quadruple (Participant, Care Provider, 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
290 mg DCCR
干预措施: 290 mg DCCR (Drug)
290 mg DCCR
干预措施: Placebo (Drug)
290 mg DCCR
干预措施: atorvastatin (Drug)
435 mg DCCR
干预措施: 435 mg DCCR (Drug)
435 mg DCCR
干预措施: Placebo (Drug)
435 mg DCCR
干预措施: atorvastatin (Drug)
135 mg fenobric acid
干预措施: 135 mg fenofibric acid (Drug)
135 mg fenobric acid
干预措施: Placebo (Drug)
135 mg fenobric acid
干预措施: atorvastatin (Drug)
Placebo
干预措施: Placebo (Drug)
Placebo
干预措施: atorvastatin (Drug)
结局指标
主要结局
The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days
时间窗: 84 days
次要结局
- The effects of DCCR on Apo B and non-HDL in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days(84 days)