A 16-Week, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Extended Release Niacin/Laropiprant in South and Southeast Asians Not on a Lipid Modulating Agent, With Decreased High-Density Lipoprotein Cholesterol and Low- Density Lipoprotein Cholesterol at or Below NCEP ATP III Goal
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 244
- 主要终点
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16
研究概览
简要总结
The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (LMT); the population will comprise participants with low to moderate risk for coronary heart disease (CHD), low high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or mildly elevated triglyceride (TG) levels.
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
ERN/LRPT group
All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive ERN/LRPT for 16 weeks.
干预措施: ERN/LRPT (Drug)
Placebo group
All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive placebo for 16 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16
时间窗: Baseline and Weeks 12 to 16
The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.
次要结局
- Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16(Baseline and Week 16)
- Percent Change From Baseline in Triglycerides (TG) at Week 16(Baseline and Week 16)
- Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16(Baseline and Week 16)
- Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16(Baseline and Week 16)
- Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16(Baseline and Week 16)
- Percent Change From Baseline in HDL-C at Week 16(Baseline and Week 16)
- Percent Change From Baseline in Non-HDL-C at Week 16(Baseline and Week 16)
- Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16(Baseline and Week 16)