NCT06682000已完成3 期
A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of DWC202404 and DWC202314 Combination Therapy in Patients With Essential Hypertension Inadequately Controlled on DWC202404 Monotherapy
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2025年1月20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
- 192
- 试验地点
- 1
- 主要终点
- Change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline
研究概览
简要总结
A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of DWC202404 and DWC202314 Combination Therapy in Patients with Essential Hypertension Inadequately Controlled on DWC202404 Monotherapy
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
- •Average systolic blood pressure (MSSBP) measured at the time of screening meet the following criteria (a) If anti-hypertensive drugs are not being administered: 140 mmHg ≤ MSSBP < 180 mmHg (b) If anti-hypertensive drugs are being administered: 130 mmHg ≤ MSSBP < 180 mmHg
排除标准
- •If the blood pressure measured at the time of screening and randomization is MSDBP ≥ 110 mmHg
- •Those whose blood pressure differences measured on both arms at the time of screening are MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg
研究组 & 干预措施
DWC202404 + DWC202314
Experimental
干预措施: DWC202404, DWC202314 (Drug)
DWC202404 + DWC202314P
Placebo Comparator
干预措施: DWC202404, DWC202314P (Drug)
结局指标
主要结局
Change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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