NCT07297797进行中（未招募）2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-9563 in Patients With Mild to Moderate Hypertension
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 6
研究概览
简要总结
This study aims to evaluate the efficacy and safety of HRS-9563 in patients with mild to moderate hypertension, and to explore its appropriate dosage.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject voluntarily signs the informed consent form.
- •Male or female, aged ≥ 18 years and ≤ 75 years;
- •Patients with mild to moderate hypertension;
- •At the Screening and Baseline periods, the mean sitting office systolic blood pressure is > 130 mmHg, and the 24-hour mean systolic blood pressure assessed by ABPM at Screening is ≥ 130 mmHg and < 160 mmHg.
排除标准
- •Secondary hypertension;
- •Orthostatic hypotension;
- •Type 1 diabetes or poorly controlled type 2 diabetes;
- •Occurrence of any cardiovascular or cerebrovascular event within 6 months prior to screening;
- •Presence of uncontrolled severe arrhythmia within 6 months prior to screening;
- •Suspected allergy to the investigational drug or any of its components;
- •Other diseases requiring Renin-Angiotensin-Aldosterone System (RAAS) inhibitor therapy, besides hypertension;
- •Any blood biochemical indicator during screening or baseline did not meet the standards in the exclusion criteria;
- •Use of any medication affecting blood pressure within 4 weeks prior to screening, or planned use during the study period;
研究组 & 干预措施
Treatment group C: HRS-9563 or Placebo Injection; Medium to high dose
Experimental
干预措施: sodium chloride injection (Drug)
Treatment group D: HRS-9563 or Placebo Injection; high dose
Experimental
干预措施: sodium chloride injection (Drug)
Treatment group D: HRS-9563 or Placebo Injection; high dose
Experimental
干预措施: HRS-9563 Injection (Drug)
Treatment group C: HRS-9563 or Placebo Injection; Medium to high dose
Experimental
干预措施: HRS-9563 Injection (Drug)
Treatment group A: HRS-9563 or Placebo Injection; low dose
Experimental
干预措施: HRS-9563 Injection (Drug)
Treatment group B: HRS-9563 or Placebo Injection; Intermediate dose
Experimental
干预措施: HRS-9563 Injection (Drug)
Treatment group B: HRS-9563 or Placebo Injection; Intermediate dose
Experimental
干预措施: sodium chloride injection (Drug)
Treatment group A: HRS-9563 or Placebo Injection; low dose
Experimental
干预措施: sodium chloride injection (Drug)
结局指标
主要结局
Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 6
时间窗: at 6 months after initiation of administration
次要结局
- Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 3(at 3 months after initiation of administration)
- Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 9(at 9 months after initiation of administration)
- Change from baseline in 24-hour mean diastolic blood pressure assessed by ABPM at month 3(at 3 months after initiation of administration)
- Change from baseline in 24-hour mean diastolic blood pressure assessed by ABPM at month 6(at 6 months after initiation of administration)
- Change from baseline in 24-hour mean diastolic blood pressure assessed by ABPM at month 9(at 9 months after initiation of administration)
- Change from baseline in mean sitting office systolic blood pressure at month 3;(at 3 months after initiation of administration)
- Change from baseline in mean sitting office systolic blood pressure at month 6;(at 6 months after initiation of administration)
- Change from baseline in mean sitting office systolic blood pressure at month 9;(at 9 months after initiation of administration)
- Change from baseline in mean sitting office diastolic blood pressure at month 3;(at 3 months after initiation of administration)
- Change from baseline in mean sitting office diastolic blood pressure at month 6;(at 6 months after initiation of administration)
- Change from baseline in mean sitting office diastolic blood pressure at month 9;(at 9 months after initiation of administration)
研究者
研究点 (1)
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