NCT00479388已完成3 期
A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of Extended-release (ER) Niacin/Laropiprant in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,216
- 主要终点
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12
研究概览
简要总结
This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia
- •Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria
排除标准
- •Patient whose LDL-C values are not within protocol specified range
研究组 & 干预措施
1
Other
One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
干预措施: niacin (+) laropiprant (Drug)
结局指标
主要结局
Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12
时间窗: Baseline and 12 Weeks
次要结局
- Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12(Baseline and 12 Weeks)
- Percent Change From Baseline in Triglycerides at Week 12(Baseline and 12 Weeks)
研究者
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