跳至主要内容
临床试验/NCT02250105
NCT02250105已完成2 期

Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia

Arisaph Pharmaceuticals Inc5 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年9月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
80
试验地点
5
主要终点
Change in Triglyceride levels

研究概览

简要总结

This study is to evaluate the efficacy and safety of ARI-3037MO 3g BID compared to placebo in reducing triglyceride (TG) levels of subjects with severe (≥500 mg/dL and <2,000 mg/dL) hypertriglyceridemia. Eligible patients will enter a 4- to 6-week lead-in period (6-week washout for subjects on non-statin lipid-lowering therapy [subjects may remain on statins during this period], 4 weeks for patients on statins only or not receiving any type of lipid-lowering therapy), followed by qualifying fasting TG measurements at visits 2 and 3, at least 7 days apart. If the baseline TG value is > 500 mg/dL and < 2,000 mg/dL, the qualified subjects will be randomized at visit 4 and enter the double-blind, 12-week efficacy and safety assessment phase. End-of-study lipid levels will be assessed on visits 6 and 7 (weeks 11 and 12 average). A final closeout and safety assessment visit will be done 14 weeks post randomization

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

ARI-3037MO

Active Comparator

ARI-3037MO 3g bid orally for 12 weeks

干预措施: ARI-3037MO (Drug)

Placebo

Placebo Comparator

Matching placebo 3g bid orally for 12 weeks

干预措施: Placebo (Drug)

结局指标

主要结局

Change in Triglyceride levels

时间窗: 12 weeks

次要结局

  • Change in LDL cholesterol(12 weeks)
  • Change in HDL cholesterol(12 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (5)

Loading locations...

相似试验