NCT04858308Unknown3 期
Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.
Yooyoung Pharmaceutical Co., Ltd.3 个研究点 分布在 1 个国家目标入组 554 人开始时间: 2021年1月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 554
- 试验地点
- 3
- 主要终点
- Percent change (%) of non-HDL-C from baseline
研究概览
简要总结
Phase 3 study to evaluate the effiacay and safety of YYC506
详细描述
Phase 3 study to evaluate the effiacay and safety of YYC506 in patients with complex dyslipidemia where LDL-C is properly controlled but TG and HDL-C levels are not regulated by Atorvastatin alone.
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)
盲法说明
Double-blind.
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A man or woman over 19 years old.
- •LDL-C properly controlled, TG, HDL-C is not properly controlled
- •Sign on ICF prior to study participation
排除标准
- •History of Fibromyalgia, Myopathy etc (CK ≥ 2XULN)
- •Uncontrolled hypo-thyroidism (TSH≥1.5XULN)
- •Severe renal impairemnet (Creainine clearance < 30mL/min) etc.
研究组 & 干预措施
Test Group
Active Comparator
Take both YYC506 and Placebo(Control)
干预措施: YYC506 (Drug)
Test Group
Active Comparator
Take both YYC506 and Placebo(Control)
干预措施: Control Placebo (Drug)
Control Group
Active Comparator
Take both Contral and Placebo(YYC506)
干预措施: Control (Drug)
Control Group
Active Comparator
Take both Contral and Placebo(YYC506)
干预措施: YYC506 Placebo (Drug)
结局指标
主要结局
Percent change (%) of non-HDL-C from baseline
时间窗: from baseline at 12 weeks
non HDL-C = TC - HDL-C
次要结局
- Percent change (%) of diabetes parameters(from baseline at 4, 8, 12, 24 weeks)
- Percent change (%) of lipid parameters(from baseline at 4, 8, 12, 24 weeks)
- Percent change (%) of non-HDL-C(from baseline at 4, 8, 14 weeks.)
研究者
研究点 (3)
Loading locations...
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