A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients With or Without Statin Intolerance
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 349
- 主要终点
- Percent change in calculated low density lipoprotein-cholesterol (LDL-C)
研究概览
简要总结
The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance.
详细描述
Hypercholesterolemic patients either with or without a history of statin intolerance (1:1 ratio) will be randomized to receive once daily by mouth capsules containing either ETC-1002, ezetimibe, or ETC-1002 + ezetimibe. This study will explore the safety and efficacy of concomitant administration of ETC-1002 and ezetimibe, while also exploring the effect of ezetimibe on ETC-1002 systemic exposure.
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
- •Statin intolerant and statin tolerant
- •Fasting LDL-C between 130 mg/dL and 220 mg/dL
- •Fasting triglyceride less than or equal to 400 mg/dL
- •Body mass index (BMI) between 18 and 45 kg/m2
排除标准
- •History or current clinically significant cardiovascular disease
- •History or current type 1 diabetes or uncontrolled type 2 diabetes
- •Use of metformin or thiazolidinediones (TZD) within 3 months of screening
- •History of joint symptoms difficult to differentiate from myalgia
- •Uncontrolled hypothyroidism
- •Liver disease or dysfunction
- •Renal dysfunction or nephritic syndrome
- •Gastrointestinal (GI) conditions or prior GI procedures
- •HIV or AIDS
- •History or malignancy
- •History or drug or alcohol abuse within last 2 years
- •Use of experimental or investigational drugs within 30 days of screening
- •Use of ETC-1002 in a previous clinical study
研究组 & 干预措施
ETC-1002 120 mg/day
Orally, once daily in morning as capsules
干预措施: ETC-1002 (Drug)
ETC-1002 180 mg/day
Orally, once daily in morning as capsules
干预措施: ETC-1002 (Drug)
ezetimibe 10mg/day
Orally, once daily in morning as capsules
干预措施: Ezetimibe (Drug)
ETC-1002 120 mg/day + ezetimibe 10mg/day
Orally, once daily in morning
干预措施: ETC-1002 (Drug)
ETC-1002 120 mg/day + ezetimibe 10mg/day
Orally, once daily in morning
干预措施: Ezetimibe (Drug)
ETC-1002 180 mg/day + ezetimibe 10mg/day
Orally, once daily in morning
干预措施: ETC-1002 (Drug)
ETC-1002 180 mg/day + ezetimibe 10mg/day
Orally, once daily in morning
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Percent change in calculated low density lipoprotein-cholesterol (LDL-C)
时间窗: Baseline and 12 weeks
次要结局
- Percent change in other lipid measures non high density lipoprotein cholesterol (nonHDL-C)(Baseline and 12 weeks)
- Safety using adverse event reports; vital signs(up to 21 weeks including screening)
- Percent change in Apolipoprotein B (ApoB)(Baseline and 12 weeks)
- Percent change in high sensitivity C-reactive protein (hsCRP)(Baseline and 12 weeks)
- Safety using adverse event reports; clinical laboratory results(up to 21 weeks including screening)
- Safety using adverse event reports; rates of muscle-related adverse(up to 21 weeks including screening)