A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Drug Interaction Study to Evaluate the Safety, Tolerability and Effect on Atorvastatin Pharmacokinetics of ETC-1002 Added to Atorvastatin 10 mg/Day in Subjects With Hypercholesterolemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites
研究概览
简要总结
This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.
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
- •For subjects on current daily statin therapy - LDL-C 100-220 mg/dL and triglycerides <350 mg/dL (prior to switching to sponsor -provided atorvastatin 10 mg/day and stopping all other lipid-regulating drugs and supplements) at the S1 Visit,
- •For subjects not on current daily statin therapy - LDL-C ≥ 110 mg/dL and ≤ 220 mg/dL
排除标准
- •Acute significant cardiovascular disease
- •Uncontrolled hypertension
研究组 & 干预措施
ETC-1002
ETC-1002 treatment group, oral once daily
干预措施: ETC-1002 (Drug)
ETC-1002
ETC-1002 treatment group, oral once daily
干预措施: Atorvastatin (Drug)
Placebo
Placebo treatment group, oral once daily
干预措施: Placebo (Drug)
Placebo
Placebo treatment group, oral once daily
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites
时间窗: 4 and 8 weeks
Peak plasma concentration (Cmax) of atorvastatin and its active metabolites
时间窗: 4 and 8 weeks
Number of subjects with adverse events, clinical lab abnormalities and other safety findings
时间窗: 8 weeks
次要结局
- Percent change in other lipids and cardio-metabolic risk factors(2, 4, 6 and 8 weeks)
- Percent change in LDL-C(2, 4, 6 and 8 weeks)