NCT06438172已完成3 期
A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients with Essential Hypertension
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 249 人开始时间: 2024年3月25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
- 249
- 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 multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 compared to RLD2001-1 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
- •Orthostatic hypotension with symptoms within 3 months prior to visit
- •Secondary hypertensive patient or suspected to be
- •Uncontrolled diabetes mellitus(HbA1c > 9%) or type I diabetes mellitus
- •Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
- •Severe heart disease or severe neurovascular disease
- •Moderate or malignant retinopathy
- •Clinically significant hematological finding
- •Severe renal diseases (eGFR<30mL/min/1.73m2)
- •Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)
- •Hypokalemia or Hyperkalemia(K<3.5mmol/L or K ≥ 5.5mmol/L)
- •Hyponatremia or Hypernatremia(Na<135mmol/L or Na ≥ 155mmol/L)
- •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
HCP1803-3
干预措施: HCP1803-3 (Drug)
Experimental
Experimental
HCP1803-3
干预措施: HPP2002-1 (Drug)
Active Comparator
Active Comparator
RLD2001-1
干预措施: RLD2001-1 (Drug)
Active Comparator
Active Comparator
RLD2001-1
干预措施: HPP2003-3 (Drug)
结局指标
主要结局
Change from baseline in sitting systolic blood pressure
时间窗: baseline, 8 weeks
次要结局
- Blood pressure response rate(4 weeks, 8 weeks)
- Treatment response rate(4 weeks, 8 weeks)
- Change from baseline in sitting distolic blood pressure(baseline, 4 weeks, 8 weeks)
- Change from baseline in pulse pressure(baseline, 4 weeks, 8 weeks)
- Change from baseline in sitting systolic blood pressure(baseline, 4 weeks)
- Proportion of subjects achieving blood pressure control(4 weeks, 8 weeks)
研究者
研究点 (1)
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