NCT00092820已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Plasma sitosterol levels after 52 weeks.
研究概览
简要总结
This is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.
详细描述
The duration of treatment is 52 weeks.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with elevated sitosterol levels while taking current medication
排除标准
- •Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
结局指标
主要结局
Plasma sitosterol levels after 52 weeks.
次要结局
- Plasma LDL-C and plasma campesterol. Safety and tolerability.
研究者
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