NCT01824238已完成3 期
A 12-Week, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Therapies in Japanese Patients With Heterozygous Familial Hypercholesterolemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Percentage of Participants who Experience at Least One Adverse Event (AE)
研究概览
简要总结
This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If female, cannot be of reproductive potential
- •Diagnosed with heterozygous familial hypercholesterolemia
- •Have been treated with an appropriate and
- •stable dose of statin± other lipid-lowering medication(s) for at least 6 weeks
排除标准
- •Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
- •Homozygous familial hypercholesterolemia
- •Severe chronic heart failure
- •Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months
研究组 & 干预措施
Anacetrapib
Experimental
Participants will receive 100-mg anacetrapib tablet, orally, once-daily for 12 weeks.
干预措施: Anacetrapib (Drug)
Placebo
Placebo Comparator
Participants will receive placebo tablet, orally, once daily for 12 weeks.
干预措施: Placebo for anacetrapib (Drug)
结局指标
主要结局
Percentage of Participants who Experience at Least One Adverse Event (AE)
时间窗: 12 weeks
Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
时间窗: Baseline and Week 12
次要结局
- Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)(Baseline and Week 12)
- Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)(Baseline and Week 12)
- Percent Change from Baseline in Lipoprotein(a) (Lp[a])(Baseline and Week 12)
- Percent Change from Baseline in Non-HDL-C(Baseline and Week 12)
- Percent Change from Baseline in Apolipoprotein B (Apo-B)(Baseline and Week 12)
研究者
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