A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
2026年8月27日 更新者:Shandong Suncadia Medicine Co., Ltd.
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
The study is being conducted to evaluate the efficacy and safety of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension.
To explore the optimal use of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension。
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
914
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Xue Dong
- 电话号码:13511659605
- 邮箱:xue.dong@hengrui.com
研究联系人备份
- 姓名:Ru Lin
- 电话号码:15521381683
- 邮箱:ru.lin.rl7@hengrui.com
学习地点
-
-
Chongqing Municipality
-
Chongqing、Chongqing Municipality、中国、400042
- Army Characteristic Medical Center of the People's Liberation Army
-
首席研究员:
- Chunyu Zeng
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200080
- Zhongshan hospital, Fudan university
-
首席研究员:
- Xiaoqiang Ding
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Male or female, aged ≥ 18 and < 80 years ;
- Mean trough seated SBP ≥ 140 mmHg and < 170 mmHg at both screening and randomization visits.
Meet one of the following two criteria:
- Meet the criteria for uncontrolled hypertension;
- Meet the criteria for resistant hypertension;
- Serum potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L ;
- Voluntarily sign the ICF prior to the study;
- Have no plan for fertility from the time of signing the ICF until 4 weeks after the last dose.
Exclusion Criteria:
- Mean trough seated DBP ≥ 110 mmHg at randomization.
- Have a known secondary cause of hypertension, including but not limited to: renal artery stenosis, coarctation of the aorta, uncontrolled or untreated hyperthyroidism/hypothyroidism, pheochromocytoma, or Cushing's syndrome.
- History of adrenal insufficiency at screening.
- Presence of severe structural heart disease at screening, including severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, rheumatic heart disease, or congenital heart disease.
- Presence of persistent atrial fibrillation or any arrhythmia requiring treatment at screening; or resting heart rate < 45 bpm or > 110 bpm.
- New York Heart Association (NYHA) Class III-IV heart failure at screening.
- Undergone CT angiography (CTA) or colonoscopy within 1 month prior to screening.
- Undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months prior to screening, or plan to undergo PCI, CABG, carotid or peripheral artery revascularization during the study period.
- History of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalization for heart failure within 6 months prior to screening.
- Within 6 months prior to screening, presence of clinically significant diseases in the following systems that, in the investigator's judgment, may interfere with the study results or pose additional risk to the administration of the investigational product, including but not limited to: respiratory, digestive, endocrine, immune, urinary, hematologic, neurologic, or psychiatric disorders.
- History of malignancy within 5 years prior to screening.
- Use of strong inhibitors/inducers of cytochrome P450 3A4 (CYP3A4) within 1 week prior to screening ,or moderate inhibitors/inducers.
- Use of mineralocorticoid receptor antagonists (MRAs) and/or potassium-sparing diuretics (e.g., spironolactone, eplerenone, finerenone, amiloride, triamterene, etc.) within 4 weeks prior to randomization.
- Use of aldosterone synthase inhibitors (ASIs) within 4 weeks prior to randomization.
- Concomitant use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) within 4 weeks prior to randomization.
- Treatment with potassium binders within 2 months prior to screening.
Presence of any of the following laboratory abnormalities:
- eGFR < 45 mL/min/1.73 m² ;
- HbA1c > 10.5%;
- Serum sodium < 135.0 mmol/L;
- ALT ≥ 3 × ULN;
- AST ≥ 3 × ULN;
- Total bilirubin ≥ 2 × ULN.
- Body mass index (BMI) > 35 kg/m².
- Run-in period placebo compliance < 80% or > 120% at randomization.
- Known or suspected allergy to MRAs, the investigational product, or any of its excipients.
- Treatment with any other investigational product within 90 days or 5 half-lives prior to screening .
- Women of childbearing potential (WOCBP) who are pregnant, breastfeeding, plan to become pregnant during the study, or are unable to use highly effective contraceptive measures; or male participants who are unable to use highly effective contraceptive measures.
- Occupation or working schedule requiring regular night shifts or similar circumstances that may interfere with study procedures.
- Any other condition that, in the investigator's judgment, may compromise participant safety or interfere with the assessment of study results.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Treatment group A: HRS-1780 tablet Dose 1
|
HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
|
|
实验性的:Treatment group B: HRS-1780 tablet Dose 2
|
HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
|
|
实验性的:Treatment group C: HRS-1780 tablet Dose 3
|
HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
|
|
安慰剂比较:Treatment group D: HRS-1780 tablet placebo
|
HRS-1780 tablet placebo
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change from baseline in trough seated SBP at Week 12
大体时间:baseline and Week 12
|
baseline and Week 12
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change from baseline in trough seated DBP at Week 12
大体时间:baseline and Week 12
|
baseline and Week 12
|
|
Change from baseline in trough seated SBP at Week 8
大体时间:baseline and Week 8
|
baseline and Week 8
|
|
Proportion of participants achieving trough seated blood pressure < 140/90 mmHg at Week 12
大体时间:Week 12
|
Week 12
|
|
Proportion of participants achieving trough seated SBP < 130 mmHg at Week 12
大体时间:Week 12
|
Week 12
|
|
Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP at Week 12
大体时间:baseline and Week 12
|
baseline and Week 12
|
|
Change from baseline in daytime and nighttime mean SBP measured by 24-hour ABPM at Week 12
大体时间:baseline and Week 12
|
baseline and Week 12
|
|
Change from baseline in daytime and nighttime mean DBP measured by 24-hour ABPM at Week 12
大体时间:baseline and Week 12
|
baseline and Week 12
|
|
Change from randomized withdrawal baseline (Week 44) in trough seated SBP at Week 52
大体时间:Week 44 and Week 52
|
Week 44 and Week 52
|
|
Proportion of participants with eGFR decline ≥ 30% during the treatment period
大体时间:baseline and treatment period
|
baseline and treatment period
|
|
Proportion of participants with serum potassium > 6.0 mmol/L during the treatment period
大体时间:treatment period
|
treatment period
|
|
Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean DBP at Week 12
大体时间:baseline and Week 12
|
baseline and Week 12
|
|
Proportion of participants with serum potassium > 5.5 mmol/L and ≤ 6.0 mmol/L during the treatment period
大体时间:treatment period
|
treatment period
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2029年4月1日
研究完成 (估计的)
2029年4月1日
研究注册日期
首次提交
2026年7月13日
首先提交符合 QC 标准的
2026年7月13日
首次发布 (实际的)
2026年7月16日
研究记录更新
最后更新发布 (实际的)
2026年9月1日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- HRS-1780-302
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.