NCT06671392已完成3 期
A Multi-center, Randomized, Double-blind, Parallel Design, Phase III Study to Evaluate and Compare the Efficacy and Safety of DWC202405/DWC202313 and DWC202314 Combination Therapy to DWC202405/DWC202313 in Patients With Essential Hypertension Inadequately Controlled With DWC202405
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2025年2月24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
- 198
- 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 Multi-center, Randomized, Double-blind, Parallel design, Phase III study to Evaluate and Compare the Efficacy and Safety of DWC202405/DWC202313 and DWC202314 Combination Therapy to DWC202405/DWC202313 in Patients with Essential Hypertension Inadequately Controlled with DWC202405
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) and average diastolic blood pressure (MSDBP) measured at the time of screening meet the following criteria (a) If antihypertensive drugs are being administered: 140 mmHg ≤ MSSBP < 180 mmHg and MSDBP < 110 mmHg However, the criteria of 130 mmHg ≤ MSSBP < 180 mmHg and MSDBP < 110 mmHg are applied to patients with the following diseases.
排除标准
- •If the blood pressure measured at the time of screening and randomization is MSSBP ≥ 180 mmHg or 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
DWC202405
Experimental
干预措施: DWC202405 (Drug)
DWC202405, DWC202314 / DWC202313, DWC202314
Experimental
干预措施: DWC202405, DWC202314 (Drug)
DWC202405, DWC202314 / DWC202313, DWC202314
Experimental
干预措施: DWC202313, DWC202314 (Drug)
DWC202405, DWC202314P / DWC202313, DWC202314P
Placebo Comparator
干预措施: DWC202405, DWC202314P (Drug)
DWC202405, DWC202314P / DWC202313, DWC202314P
Placebo Comparator
干预措施: DWC202313, 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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