NCT03874260Unknown4 期
A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- rate of change for Triglyceride based on baseline
研究概览
简要总结
A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both male and female who are over 19-year-old
- •200mg/dl≤TG<500mg/dl
- •Desired value of LDL-c
- •very high risk < 70
- •high risk < 100
- •moderate risk <130
- •low risk < 160
排除标准
- •patient who is going to have an operation during this study
- •patient who has allergy or hypersensitivity of fenofibrate
- •patient who has abnormal ECG
研究组 & 干预措施
statin / fenofibrate
Experimental
stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg)+ choline fenofibrate 178.8mg / once a day, P.O
干预措施: Fenofibrate (Drug)
statin / fenofibrate placebo
Placebo Comparator
stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O
干预措施: Fenofibrate (Drug)
结局指标
主要结局
rate of change for Triglyceride based on baseline
时间窗: 8week
次要结局
未报告次要终点
研究者
研究点 (1)
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