To Assess the Long-term Efficacy and Safety of Combined Therapy With Ezefeno Tab. in Patients With Dyslipidemia Who do Not Achieve Adequate Control of Non-HDL-C Levels Even With Moderate-intensity Monotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,958
- 试验地点
- 1
- 主要终点
- major adverse cardiovascular events and diabetic microvascular events for 48 months
研究概览
简要总结
The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:
- major adverse cardiovascular events within 48 months of the trial duration
- microvascular events within 48 months of the trial duration
详细描述
A prospective, randomized, open-label, parallel, multicenter, active-drug-controlled clinical trial to assess the long-term efficacy and safety of Combined Therapy with Ezefeno Tab. in patients with dyslipidemia who do not achieve adequate control of Non-HDL-C levels even with Moderate-intensity monotherapy.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes diagnosed by American Diabetes Association criteria
- •Age ≥ 19 years
- •Non-HDL-C ≥100 mg/dL, TG ≥200, <500 mg/dL on moderate-intensity statins
- •with cardiovascular risk factor
排除标准
- •Pregnant or breastfeeding women
- •Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)
- •Patient with myopathy and rhabdomyolysis
- •AST/ALT more than 3 ULN
- •Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption
研究组 & 干预措施
Treatment group
Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
干预措施: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin (Drug)
Control group
Dose escalation of moderate-intensity statin
干预措施: Dose escalation of moderate-intensity statin (Drug)
结局指标
主要结局
major adverse cardiovascular events and diabetic microvascular events for 48 months
时间窗: 48month from baseline
major adverse cardiovascular events and diabetic microvascular events for 48 months
次要结局
- proportion of patients achieving Non-HDL-C less than 100mg/dL(48month from baseline)
- proportion of patients achieving LDL less than 70mg/dL(48month from baseline)
- change in Non-HDL-C at 48month from baseline(48month from baseline)
- change in LDL at 48month from baseline(48month from baseline)
- change in HDL-C at 48month from baseline(48month from baseline)
- change in TG at 48month from baseline(48month from baseline)
- change in LDL-C/HDL-C ratio at 48month from baseline(48month from baseline)
- change in TC/HDL-C ratio at 48month from baseline(48month from baseline)
研究者
Sin Gon Kim
professor
Korea University Anam Hospital