A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Triplet Therapy With Bempedoic Acid (ETC 1002) 180 mg, Ezetimibe 10 mg, and Atorvastatin 20 mg in Patients With Elevated LDL C
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 11
- 主要终点
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6
研究概览
简要总结
The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated LDL cholesterol.
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
- •Fasting LDL-cholesterol between 130 - 189 mg/dL at screening following washout of all LDL-C-lowering drugs and nutritional supplements
- •Men and nonpregnant, nonlactating women
- •Sufficiently stable and suitable to undergo washout of all LDL-C-lowering drugs and nutritional supplements for 12 weeks
排除标准
- •Fasting blood triglycerides greater than or equal to 400 mg/dL
- •Body Mass Index (BMI) greater than 50 kg/m2
- •History of clinically significant cardiovascular disease
- •History of type 1 or type 2 diabetes
研究组 & 干预措施
placebo
Matching placebos taken orally, daily.
干预措施: Placebo (Other)
Triplet Therapy
Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.
干预措施: Bempedoic acid 180mg (Drug)
Triplet Therapy
Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.
干预措施: Ezetimibe 10mg (Drug)
Triplet Therapy
Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.
干预措施: Atorvastatin 20mg (Drug)
结局指标
主要结局
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6
时间窗: Baseline; Week 6
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Percent change from Baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing LDL-C values were imputed using last observation carried forward (LOCF), with only post-Baseline values carried forward. If LDL-C was measured (i.e., if TG was \>400 mg/dL or LDL-C was \<50 mg/dL), the measured values were used in the analysis.
次要结局
- Percent Change From Baseline in Lipid Profile Parameters at Week 6(Baseline; Week 6)
- Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 6(Baseline; Week 6)
- Number of Participants With LDL-C Reduction ≥50% From Baseline at Week 6(Baseline; Week 6)
- Number of Participants With LDL-C <70 mg/dL at Week 6(Week 6)