The Addition of Evacetrapib to Atorvastatin Compared to Placebo, High Intensity Atorvastatin, and Atorvastatin With Ezetimibe to Evaluate LDL-C Lowering in Patients With Primary Hyperlipidemia - The ACCENTUATE Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 366
- 试验地点
- 63
- 主要终点
- Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)
研究概览
简要总结
The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening
- •Have an LDL-C >70 mg/deciliter(dL) or non-HDL-C >100 mg/dL
- •Have screening triglycerides ≤400 mg/dL (≤4.5 millimoles/Liter)
- •Individuals with ASCVD and/or individuals with type 1 or type 2 diabetes
排除标准
- •Have a hemoglobin A1c (HbA1c) >9.5%
- •New York Heart Association (NYHA) class III or IV congestive heart failure
- •History of either a transient ischemic stroke or ischemic stroke <30 days
- •History of acute coronary syndrome (ACS) <30 days
研究组 & 干预措施
Atorvastatin + Evacetrapib
Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
干预措施: Evacetrapib (Drug)
Atorvastatin + Evacetrapib
Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
干预措施: Atorvastatin (Drug)
Atorvastatin + Evacetrapib
Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
干预措施: Placebo (Drug)
Atorvastatin 80 mg
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
干预措施: Atorvastatin (Drug)
Atorvastatin 80 mg
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
干预措施: Placebo (Drug)
Atorvastatin + Ezetimibe
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
干预措施: Atorvastatin (Drug)
Atorvastatin + Ezetimibe
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
干预措施: Ezetimibe (Drug)
Atorvastatin + Ezetimibe
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
干预措施: Placebo (Drug)
Atorvastatin 40 mg
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
干预措施: Atorvastatin (Drug)
Atorvastatin 40 mg
Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)
时间窗: Baseline, 3 Months
Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
次要结局
- Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)(Baseline, 3 Months)
- Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)(Baseline, 3 Months)
- Percent Change From Baseline to 3 Months in Non-HDL-C(Baseline, 3 Months)
- Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)(Baseline, 3 Months)
- Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity(Baseline, 3 Months)
- Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])(Baseline, 3 Months)