A Double-Blind Efficacy and Safety Study of Evacetrapib Followed by an Open-Label Extension in Japanese Patients With Primary Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as evacetrapib in Japanese participants with primary hypercholesterolemia. The double blind treatment period will last for 12 weeks and the open-label extension period will last for an additional 40 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese outpatients who are diagnosed with primary hypercholesterolemia with LDL-C levels (measured by a direct method at baseline) that meet the following criteria. (Participant categories are based on the definition in Japan Atherosclerosis Society 2012 guidelines.)
- •Category I: 160 mg/deciliter (dL)≤LDL-C<200 mg/dL
- •Category II: 140 mg/dL≤LDL-C<175 mg/dL
- •Category III: 120 mg/dL≤LDL-C<150 mg/dL
- •Have triglycerides (TG) ≤400 mg/dL.
- •Have HDL-C <100 mg/dL.
排除标准
- •Participants on LDL apheresis or plasma apheresis.
- •Participants with secondary hypercholesterolemia or familial hypercholesterolemia.
- •Any planned angiography. If angiography is planned, participants may be screened and enrolled after all such planned procedures are completed.
- •History of any of the following any conditions:
- •Stable angina or acute coronary syndrome (unstable angina, myocardial infarction), old myocardial infarction or a coronary revascularization procedure including stent placement, or symptomatic carotid artery disease
- •peripheral arterial disease
- •ischemic stroke or transient ischemic attack (TIA)
- •intracranial hemorrhage
- •abdominal aortic aneurysm
- •Have systolic blood pressure (SBP) >160 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) >100 mm Hg.
- •Have a hemoglobin A1c ≥8.4% (National Glycohemoglobin Standardization Program).
- •During the study period, participants who plan to use, are likely to require, or unwilling or unable to stop with adequate washout any prescription, over the counter medication, supplements or health foods with the intent to treat serum lipids (LDL-C, HDL-C, TG) including but not limited to these classes of drugs: statin, ezetimibe, bile acid sequestrant, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Participants taking probucol, fibrate or nicotinic agents within 8 weeks before screening are excluded from the study.
- •Have been exposed to cholesteryl ester transfer protein inhibitors (e.g., anacetrapib or dalcetrapib).
研究组 & 干预措施
Evacetrapib
130 milligrams (mg) evacetrapib given orally (PO) once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.
干预措施: Evacetrapib (Drug)
Placebo
Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
干预措施: Evacetrapib (Drug)
Placebo
Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification
时间窗: Baseline, Week 12
Least Square Mean (LS mean) using mixed model repeated measures (MMRM) adjusted for baseline, treatment, visit , and treatment\*visit, where the participant is a random effect.
次要结局
- Percent Change From Baseline in Lipoprotein-a(Baseline, Week 12, Week 52)
- Percent Change From Baseline in Apolipoprotein A-I(Baseline, Week 12, Week 52)
- Percent Change From Baseline in Apolipoprotein B(Baseline, Week 12, Week 52)
- Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)(Baseline, Week 12)
- Percent Change From Baseline in LDL-C (Direct)(Baseline, Week 12)
- Percent Change From Baseline in Non HDL-C(Baseline, Week 12)