NCT00092898已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to An Ongoing Regimen of Ezetimibe 10 mg in Patients 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
- 30
- 主要终点
- Sitosterol concentrations after 26 weeks.
研究概览
简要总结
This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients.
详细描述
The duration of treatment is 26 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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry.
排除标准
- •Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.
结局指标
主要结局
Sitosterol concentrations after 26 weeks.
时间窗: After 26 weeks
次要结局
- Campesterol concentrations; Achilles tendon thickness; safety and tolerability.
研究者
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