A Phase III Efficacy And Safety Study of Ezetimibe (SCH58235) 10 mg in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Percentage of participants with an Adverse Event (AE)
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With a diagnosis of homozygous familial hypercholesterolemia
- •All females must have a negative pregnancy test prior to study entry. Women of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study, until one month after treatment.
- •Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen during the study period. ERT, HRT or raloxifene cannot be changed during study period.
- •Must follow prescribed or stricter diet, and demonstrate completion of Diet Diaries
排除标准
- •A history of mental instability, drug or alcohol abuse; or have been treated or are being treated for severe psychiatric illness which, in the opinion of the Investigator, may interfere with optimal participation in the study.
- •With underlying disease likely to limit life span to less than 1 year.
- •Have previously been randomized in any studies examining ezetimibe
- •Pregnant or lactating women.
- •With known hypersensitivity or any contraindication to statin therapy.
研究组 & 干预措施
Atorvastatin 80 mg
80 mg atorvastatin taken orally, once daily for 12 weeks
干预措施: Atorvastatin (Drug)
Atorvastatin 80 mg
80 mg atorvastatin taken orally, once daily for 12 weeks
干预措施: Placebo for Ezetimibe (Drug)
Ezetimibe + Atorvastatin 40 mg
10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks
干预措施: Atorvastatin (Drug)
Ezetimibe + Atorvastatin 40 mg
10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks
干预措施: Ezetimibe (Drug)
Ezetimibe + Atorvastatin 80 mg
10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks
干预措施: Atorvastatin (Drug)
Ezetimibe + Atorvastatin 80 mg
10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks
干预措施: Ezetimibe (Drug)
Simvastatin 80 mg
80 mg simvastatin taken orally, once daily for 12 weeks
干预措施: Simvastatin (Drug)
Simvastatin 80 mg
80 mg simvastatin taken orally, once daily for 12 weeks
干预措施: Placebo for Ezetimibe (Drug)
Ezetimibe + Simvastatin 40 mg
10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks
干预措施: Simvastatin (Drug)
Ezetimibe + Simvastatin 40 mg
10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks
干预措施: Ezetimibe (Drug)
Ezetimibe + Simvastatin 80 mg
10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks
干预措施: Simvastatin (Drug)
Ezetimibe + Simvastatin 80 mg
10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Percentage of participants with an Adverse Event (AE)
时间窗: Up to Week 12
Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly
时间窗: Baseline and Up to Week 12
次要结局
- Percent change from baseline in High-density-lipoprotein 2 cholesterol (HDL2-C)(Baseline and Up to Week 12)
- Percent change from baseline in Total Cholesterol (TC)(Baseline and Up to Week 12)
- Percent change from baseline in Triglycerides (TG)(Baseline and Up to Week 12)
- Percent change from baseline in Apolipoprotein B (Apo B)(Baseline and Up to Week 12)
- Percent change from baseline in High-density-lipoprotein cholesterol (HDL-C)(Baseline and Up to Week 12)
- Percent change from baseline in Apolipoprotein A-I (Apo A-I)(Baseline and Up to Week 12)
- Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C)(Baseline and Up to Week 12)
- Percent change from baseline in Lipoprotein(a) [Lp(a)](Baseline and Up to Week 12)
- Percent change from baseline in calculated LDL-C(Baseline and Up to Week 12)