NCT05331014已完成3 期
A Multi-center, Randomized, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients With Dyslipidemia and Hypertension.
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2021年11月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect
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 JW0101+C2101 in Patients with Dyslipidemia and Hypertension.
详细描述
Multicenter, randomized, double-blind, parallel-design, phase III clinical study
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 100 Years（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
JW0101+C2101
Experimental
LivaloVA
干预措施: LivaloVA (Drug)
JW0101+C2102
Active Comparator
LivaloV
干预措施: LivaloV (Drug)
C2101
Active Comparator
VA
干预措施: VA (Drug)
结局指标
主要结局
msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect
时间窗: week 8
change in msSBP and LDL-C level
次要结局
- efficacy and safety(week 8)
研究者
研究点 (1)
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