NCT07660796尚未招募3 期
A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2026年7月6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
- 尚未招募
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Change from baseline in sitting systolic blood pressure
研究概览
简要总结
A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension
详细描述
A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HCP1803-4 in patients with essential hypertension
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
- •Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions
- •mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
- •140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1
- •Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2
排除标准
- •Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
- •Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
- •Orthostatic hypotension with symptoms within 3 months prior to visit 1
- •Secondary hypertensive patient or suspected to be
- •Clinically significant hematological finding
- •Severe heart disease or severe neurovascular disease
- •Moderate or malignant retinopathy
- •Uncontrolled diabetes mellitus or type I diabetes mellitus
- •Active gout or hyperuricemia
- •Severe renal diseases
- •Severe or active hepatopathy
- •Hypokalemia or Hyperkalemia
- •Hyponatremia or Hypernatremia
- •Hypercalcemia
- •History of malignancy tumor
- •History of autoimmune disease
- •History of alcohol or drug abuse
- •Positive to pregnancy test, nursing mother, intention on pregnancy
- •Considered by investigator as not appropriate to participate in the clinical study with other reason
研究组 & 干预措施
Experimental
Experimental
Take HCP1803-3 once daily for 2 weeks orally, and then take HCP1803-4 once daily for 8 weeks orally.
干预措施: HCP1803-3 (Drug)
Active Comparator
Active Comparator
Take RLD2001-1 once daily for 2 weeks orally, and then take RLD2001-2 once daily for 8 weeks orally.
干预措施: RLD2001-1 (Drug)
结局指标
主要结局
Change from baseline in sitting systolic blood pressure
时间窗: Baseline, 10 weeks
次要结局
- Change from baseline in sitting systolic blood pressure(Baseline, 2 weeks, 6 weeks)
- Change from baseline in sitting diastolic blood pressure(Baseline, 2 weeks, 6 weeks, 10 weeks)
- Proportion of subjects achieving blood pressure control (sitSBP)(2 weeks, 6 weeks, 10 weeks)
- Proportion of subjects achieving blood pressure control (sitSBP, sitDBP)(2 weeks, 6 weeks, 10 weeks)
- Blood pressure response rate (sitSBP)(2 weeks, 6 weeks, 10 weeks)
- Treatment response rate(2 weeks, 6 weeks, 10 weeks)
- Blood pressure response rate (sitSBP, sitDBP)(2 weeks, 6 weeks, 10 weeks)
- Change from baseline in pulse pressure(Baseline, 2 weeks, 6 weeks, 10 weeks)
研究者
研究点 (1)
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