NCT06643130招募中3 期
A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0104+C2402 in Patients With Hypertension and Dyslipidemia
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2024年12月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Change from baseline in msSBP (Systolic Blood Pressure)
研究概览
简要总结
A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0104+C2402 in Patients with Hypertension and Dyslipidemia
详细描述
To evaluate the efficacy and safety of co-administration of JW0104+C2402 in comparison with co-administration of JW0104+C2403 or C2402 alone in patients with hypertension and 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
- •Patients with hypertension and dyslipidemia
排除标准
- •The subject not meet the specified msBP and LDL-C level
研究组 & 干预措施
JW0104+C2402
Experimental
JW0104+C2402, 8 weeks, QD (Quaque Die)
干预措施: JW0104+C2402 (Drug)
JW0104+C2403
Active Comparator
JW0104+C2403, 8 weeks, QD
干预措施: JW0104+C2403 (Drug)
C2402
Active Comparator
C2402, 8 weeks, QD
干预措施: C2402 (Drug)
结局指标
主要结局
Change from baseline in msSBP (Systolic Blood Pressure)
时间窗: week 8
Check msSBP
Percent change from baseline in LDL-C (Low-Density Lipoprotein Cholesterol)
时间窗: week 8
Check LDL-C
次要结局
- change from baseline in msSBP(week 4)
- Change and percent change from baseline in LDL-C(week 4)
研究者
研究点 (1)
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