A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg Compared to Placebo Added to Background Lipid-Modifying Therapy in Patients With Elevated LDL-C Who Are Statin Intolerant
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 345
- 试验地点
- 2
- 主要终点
- Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
研究概览
简要总结
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
- •Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
- •Be statin-intolerant (unable to tolerate 2 or more statins)
排除标准
- •Total fasting triglyceride ≥500 mg/dL
- •Renal dysfunction or nephrotic syndrome or history of nephritis
- •Body Mass Index (BMI) ≥50 kg/m2
- •Significant cardiovascular disease or cardiovascular event in the past 3 months
研究组 & 干预措施
bempedoic acid
bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
干预措施: bempedoic acid (Drug)
placebo
Matching placebo tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
干预措施: placebo (Other)
结局指标
主要结局
Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
时间窗: Baseline; Week 12
PCFB was calculated as the (\[post-Baseline (BL) value minus the BL value\] divided by the BL value ) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available, that single value was used as BL. PCFB in LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment group and stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing lipid data at Week 12 who were no longer taking study treatment, missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking study treatment, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.
次要结局
- Percent Change From Baseline in LDL-C at Week 24(Baseline; Week 24)
- Percent Change From Baseline in the Lipid Profile at Week 12(Baseline; Week 12)
- Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 12(Baseline; Week 12)
- Absolute Change From Baseline in LDL-C at Week 12 and Week 24(Baseline; Week 12; Week 24)