NCT04312698已完成3 期
A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of D013, D326 and D337 Combination Therapy in Dyslipidemia Patients With Hypertension
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change rate from baseline in LDL-C
研究概览
简要总结
Clinical Trial to Evaluate the Efficacy and Safety of CKD-386
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
- Double (Participant, Investigator)
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
- •Subjects are diagnosed with Dyslipidemia Patients with Hypertension or are being administered anti-hypertension and anti-hypertension drugs after diagnosis.
- •Subjects who agreed to participate in this clinical trial voluntarily.
排除标准
- •Subjects who were satisfied specific blood pressure levels that measured at screening period.
- •Subjects who were satisfied specific lipid levels that measured at screening period.
- •Subjects who cannot participate in a clinical trial based on the PI's judgment.
研究组 & 干预措施
Experimental Group 1
Experimental
干预措施: D013, D326, D337 (Drug)
Comparator Group 1
Placebo Comparator
干预措施: placebo of D013, D326, D337 (Drug)
Comparator Group 2
Placebo Comparator
干预措施: D013, placebo of D326, placebo of D337 (Drug)
结局指标
主要结局
Change rate from baseline in LDL-C
时间窗: 8 weeks after drug administrations
Compare experimental group 1 with comparator group 1
Change from baseline in MSSBP
时间窗: 8 weeks after drug administrations
Compare experimental group 1 with comparator group 2
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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