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临床试验/NCT00092833
NCT00092833终止3 期

An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous Sitosterolemia

Organon and Co0 个研究点目标入组 49 人开始时间: 2002年7月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
49
主要终点
Incidence of clinical and laboratory adverse experiences in in patients with homozygous FH or homozygous sitosterolemia taking ezetimibe 10 mg/day

研究概览

简要总结

The purpose of this study is to provide an investigational drug to patients with a specific type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption of non-cholesterol sterols) in a treatment use setting.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Homozygous familial hypercholesterolemia or sitosterolemia

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

Incidence of clinical and laboratory adverse experiences in in patients with homozygous FH or homozygous sitosterolemia taking ezetimibe 10 mg/day

时间窗: 3 years

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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