A Double-Blind Efficacy and Safety Study of Evacetrapib in Combination With Atorvastatin in Japanese Patients With Primary Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 149
- 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 when administered in combination with atorvastatin for 12 weeks in Japanese participants with primary hypercholesterolemia.
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
- •Must be treated with atorvastatin 10 mg/day for at least 30 days prior to study initiation.
- •Japanese outpatients who are diagnosed with primary hypercholesterolemia with LDL-C levels (measured by a direct method) 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
- •Category II: 140 mg/dL≤LDL-C
- •Category III: 120 mg/dL≤LDL-C
- •Secondary prevention: 100 mg/dL≤LDL-C
- •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 homozygous 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 conditions < 90 days prior to study initiation
- •acute coronary syndrome (unstable angina, acute myocardial infarction)
- •symptomatic peripheral arterial disease
- •invasive treatment of carotid artery disease
- •ischemic stroke or transient ischemic attack (TIA)
- •intracranial hemorrhage
- •History of abdominal aortic aneurysm.
- •Participants with a history of intolerance/hypersensitivity to ezetimibe or statins.
- •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 (OTC) 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 (except for atorvastatin 10 mg), ezetimibe, bile acid sequestrant, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Participants taking probucol, fibrate or nicotinic agents within 8 weeks before study initiation are excluded from the study.
- •Have been exposed to cholesteryl ester transfer protein (CETP) inhibitors (for example, anacetrapib or dalcetrapib).
研究组 & 干预措施
Evacetrapib
130 milligrams (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.
干预措施: Evacetrapib (Drug)
Evacetrapib
130 milligrams (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.
干预措施: Atorvastatin (Drug)
Ezetimibe
10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.
干预措施: Ezetimibe (Drug)
Ezetimibe
10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.
干预措施: Atorvastatin (Drug)
Placebo
Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.
干预措施: Atorvastatin (Drug)
Placebo
Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.
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
The mixed-effects model for repeated measures (MMRM) was used for the Least Squares Mean (LS Mean) estimates at Week 12 for LDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, Visit (4,5,6, or 7), and treatment-by-visit interaction as fixed effects, and participant as a random effect.
次要结局
- Percent Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol (HDL-C)(Baseline, Week 12)
- Percent Change From Baseline to Week 12 in Lipoprotein-a(Baseline, Week 12)
- Percent Change From Baseline to Week 12 in Non HDL-C(Baseline, Week 12)
- Percent Change From Baseline to Week 12 in LDL-C (Direct)(Baseline, Week 12)
- Percent Change From Baseline to Week 12 in Apolipoprotein A-I(Baseline, Week 12)
- Percent Change From Baseline to Week 12 in Apolipoprotein B(Baseline, Week 12)