NCT04772443Unknown3 期
A Randomized, Double-blind, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 280 人开始时间: 2021年2月最近更新:
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
- 280
- 主要终点
- LDL-C levels at week 8
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of DWJ1506 and DWJ1507 in the patients with dyslipidemia.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or over
- •Patients with LDL-C levels ≤ 250 mg/dL, TG < 500 mg/dL
- •Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study
排除标准
- •Severe congestive hear failure
- •Current active liver disease
- •The use of prohibiterd concomitant therapies
- •Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.
- •6.Women who were of childbearing potential without contraception, pregnant, or breastfeeding
研究组 & 干预措施
DWJ1506
Experimental
干预措施: DWJ1506 (Drug)
DWJ1507
Experimental
干预措施: DWJ1507 (Drug)
DWC202011
Active Comparator
干预措施: DWC202011 (Drug)
DWJ1177
Active Comparator
干预措施: DWJ1177 (Drug)
结局指标
主要结局
LDL-C levels at week 8
时间窗: Week 8
Change from baseline in LDL-C level at week 8 after administration of the IP
次要结局
未报告次要终点
研究者
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