NCT04820907已完成3 期
A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-1 in Essential Hypertension Patients.
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2020年10月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Change from baseline in mean sitting systolic blood pressure(mmHg)
研究概览
简要总结
The purpose of this study is to evaluate of efficacy and safety of HCP1904-1 and RLD2001-1 alone in patients with essential hypertension inadequately controlled on RLD2001-1 monotherapy.
详细描述
A Multi-center, Randomized, Double-blinded, Active-controlled, Parallel, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-1 in Essential Hypertension Patients
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Patients who understands the process of clinical study and voluntarily signs a peer letter
- •Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions
- •Blood pressure medication taken patients: 130mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg
- •Blood pressure medication free patients: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg
- •Visit2: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP <180mmHg, sit DBP < 110mmHg
排除标准
- •Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP
- •Orthostatic hypotension with symptoms within 3months of visit 1
- •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
- •Severe or malignant retinopathy
- •Clinically significant hematological finding
- •Severe renal diseases (eGFR<30mL/min/1.73m2)
- •Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
- •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 othe reason
研究组 & 干预措施
HCP1904-1
Experimental
干预措施: HCP1904-1 (Drug)
RLD2001-1
Active Comparator
干预措施: RLD2001-1 (Drug)
结局指标
主要结局
Change from baseline in mean sitting systolic blood pressure(mmHg)
时间窗: Week 8
次要结局
- Change from baseline in mean sitting systolic blood pressure(mmHg)(Week 4)
- Responder rate(Week 4, 8)
- Change from baseline in mean sitting diastolic blood pressure(mmHg)(Week 4,8)
- Change from baseline in mean pulse blood pressure(mmHg)(Week 4,8)
- target blood pressure reach rate(Week 4, 8)
研究者
研究点 (1)
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