A Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Adding ETC-1002 180 mg to Atorvastatin 80 mg Background Therapy in Statin-Treated Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolites
研究概览
简要总结
The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine, and to see how ETC-1002 is tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background therapy in statin-treated patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Taking daily stable statin doses for at least 4 weeks prior to screening visit.
- •LDL-C between 100-220 mg/dL for patients taking daily high-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit; or,
- •LDL-C between 115-220 mg/dL for patients taking moderate- or low-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit.
- •Must be willing to discontinue other lipid-regulating therapies during the study
排除标准
- •History of acute significant cardiovascular disease.
- •Current clinically significant cardiovascular disease.
- •History of inability to tolerate any statin at any dose due to muscle-related pain or weakness.
研究组 & 干预措施
ETC-1002 + Atorvastatin
ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily
干预措施: ETC-1002 (Drug)
ETC-1002 + Atorvastatin
ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily
干预措施: Atorvastatin (Drug)
Placebo + Atorvastatin
Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily
干预措施: Atorvastatin (Drug)
Placebo + Atorvastatin
Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolites
时间窗: 2 weeks
Fold change in Cmax from prior-to to following 2 week treatment with ETC-1002
24-hour area under the curve (AUC) pharmacokinetics of atorvastatin and its active metabolites
时间窗: 2 weeks
Fold change in AUC from prior-to to following 2 week treatment with ETC-1002
Percent change in LDL-cholesterol
时间窗: 4 weeks
Percent Change from baseline to 4 week treatment, incremental lowering of LDL-C
次要结局
- Percent change in hsCRP(4 weeks)
- Percent change in total cholesterol(4 weeks)
- Percent change in non-HDL-cholesterol(4 weeks)
- Percent change in apolipoprotein B(4 weeks)
- 24-hour post dose plasma concentration pharmacokinetics of ETC-1002 and its active metabolite(2 weeks)