NCT00145574已完成4 期
Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Colesevelam HCl Administered to Pediatric Patients With Heterozygous Familial Hypercholesterolemia on a Stable Dose of Statins or Treatment Naive to Lipid-lowering Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 194
- 主要终点
- Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8.
研究概览
简要总结
This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin, simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients
- •Ages 10 to 17 years inclusive
- •Diagnosis of heterozygous familial hypercholesterolemia
- •On a stable dose of statin monotherapy or are treatment naive to lipid- lowering agents
- •On a low-cholesterol diet
排除标准
- •Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients
研究组 & 干预措施
high dose colesevelam
Experimental
colesevelam HCl 3.750 g
干预措施: colesevelam HCl (Drug)
Low dose colesevelam
Experimental
Low dose colesevelam 1.875 g
干预措施: colesevelam HCl (Drug)
placebo
Placebo Comparator
placebo comparator
干预措施: placebo (Drug)
结局指标
主要结局
Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8.
时间窗: 8 weeks (week 8 - day 1)
Percent change in LDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline)to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.
次要结局
- Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8.(8 weeks (week 8 - day 1))
- Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8.(8 weeks (week 8 - day 1))
- Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8.(8 weeks (week 8 - day 1))
- Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8.(8 weeks (week 8 - day 1))
- Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8.(8 weeks (week 8 - day 1))
- Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8.(8 weeks (week 8 - day 1))
- Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26.(26 weeks (week 26 - day 1))
- Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26.(26 weeks (week 26 - day 1))
- Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26.(26 weeks (week 26 - day 1))
- Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26.(26 weeks (week 26 - day 1))
- Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26.(26 weeks (week 26 - day 1))
- Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26.(26 weeks (week 26 - day 1))
- Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26.(26 weeks (week 26 - day 1))
研究者
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