A Placebo-Controlled, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ETC-1002 in Patients With Hypercholesterolemia and Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6
研究概览
简要总结
This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo in participants with hypercholesterolemia and hypertension.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg
- •or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg
- •Fasting LDL-C between 100 and 220 mg/dL
- •Fasting triglycerides less than 400 mg/dL
- •Body mass index (BMI) between 18 and 45 kg/m2
排除标准
- •Known or suspected secondary hypertension or history of malignant hypertension
- •Taking more than two anti-hypertension medications at the first visit
- •History or current clinically significant cardiovascular disease
- •History or current type 1 diabetes or type 2 diabetes
研究组 & 干预措施
ETC-1002
ETC-1002 180 mg/day
干预措施: ETC-1002 (Drug)
Placebo
Placebo control
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6
时间窗: Baseline; 6 weeks
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value. For the Week 6 endpoint, missing values at Week 6 were imputed using the last observation carried forward (LOCF) procedure, with only post-Baseline values carried forward. Modified Intent-to-Treat (mITT) Population is defined as all randomized participants who received at least 1 dose of study drug, had a Baseline assessment, and had at least 1 post-Baseline assessment, excluding any assessment taken more than 2 days after a dose of study drug
次要结局
- Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) to Week 6(Baseline; 6 weeks)
- Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) to Week 6(Baseline; 6 weeks)
- Change From Baseline in Mean Daytime SBP to Week 6(Baseline; 6 weeks)
- Change From Baseline in Mean Daytime DBP to Week 6(Baseline; 6 weeks)
- Change From Baseline in Mean Nighttime SBP to Week 6(Baseline; 6 weeks)
- Change From Baseline in Mean Nighttime DBP to Week 6(Baseline; 6 weeks)
- Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) to Week 6(Baseline; 6 weeks)
- Change From Baseline in Sitting Cuff SBP to Week 6(Baseline: 6 weeks)
- Change From Baseline in Sitting Cuff DBP to Week 6(Baseline; 6 weeks)
- Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) to Week 6(Baseline; 6 weeks)
- Percent Change From Baseline in Triglycerides (TG) to Week 6(Baseline; 6 weeks)
- Percent Change From Baseline in Total Cholesterol to Week 6(Baseline; 6 weeks)
- Percent Change From Baseline in Apolipoprotein B (ApoB) to Week 6(Baseline; 6 weeks)
- Percent Change From Baseline in HDL-C to Week 6(Baseline; 6 weeks)
- Percent Change From Baseline in Free Fatty Acids (FFA) to Week 6(Baseline; 6 weeks)
- Change From Baseline in Body Weight to Week 6(Baseline; 6 weeks)
- Plasma Trough Concentrations of ETC-1002 and Metabolite ESP15228(Week 2, Week 4 and Week 6)