Efficacy, Safety, and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 248
- 主要终点
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
研究概览
简要总结
This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with Heterozygous Familial Hypercholesterolemia.
详细描述
This study consisted of 3 distinct periods. In Period 1, subjects received daily treatment for 6 weeks as part of either the ezetimibe with simvastatin group or part of the simvastatin monotherapy group. Subjects in the ezetimibe with simvastatin group received one of three treatments: coadministration of ezetimibe 10 mg/day plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. Subjects in the simvastatin monotherapy group received one of three treatments: ezetimibe placebo plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. The primary and key secondary efficacy analysis were based on the evaluations performed during Period 1 and were presented as data for subjects pooled from either the ezetimibe with simvastatin treatment groups compared with data for subjects pooled from the simvastatin monotherapy treatment groups.
In Period 2, subjects received ezetimibe 10 mg/day plus simvastatin 40 mg/day or ezetimibe placebo plus simvastatin 40 mg/day for 27 additional weeks maintaining the same treatment assignment (coadministration vs monotherapy) as in Period 1.
In Period 3, all subjects received ezetimibe 10 mg/day plus open-label simvastatin daily for 20 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent (ages 10 - 17 years) boys or girls weighing at least 88 lbs (40 kg).
- •Subjects must have high cholesterol (low density lipoprotein cholesterol [LDL-C] more than 159 mg/dL or 4.1 mmol/L) and a family history of high cholesterol.
排除标准
- •Subjects diagnosed with delayed puberty.
- •Subjects who are sensitive to simvastatin and/or ezetimibe.
- •Subjects who drink alcohol excessively or who have a history of alcohol or drug abuse within the past 2 years.
- •Subjects who are known to be HIV positive, are undergoing LDL apheresis or plasma apheresis, or have had a partial ileal bypass.
研究组 & 干预措施
Pooled subjects who received ezetimibe with simvastatin
Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
干预措施: ezetimibe with simvastatin (Drug)
Pooled subjects who received simvastatin monotherapy
Pooled subjects who received ezetimibe matching placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
干预措施: simvastatin (Drug)
结局指标
主要结局
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
时间窗: baseline to 6 weeks
Least squares mean percent change from Baseline in LDL-C at the end of Step 1 (Week 6) in the pooled groups who received ezetimibe plus simvastatin compared with pooled groups who received simvastatin monotherapy
次要结局
- Percent Change From Baseline in Total Cholesterol (TC)(baseline to 6 weeks)
- Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C)(baseline to 6 weeks)
- Percent Change From Baseline in Triglycerides (TG)(baseline to 6 weeks)
- Percent Change From Baseline in Apolipoprotein B (Apo B)(baseline to 6 weeks)
- Percent Change From Baseline in HDL-C(baseline to 6 weeks)