NCT07708441尚未招募2 期
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.
Shandong Suncadia Medicine Co., Ltd.2 个研究点 分布在 1 个国家目标入组 914 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 914
- 试验地点
- 2
- 主要终点
- Change from baseline in trough seated SBP at Week 12
研究概览
简要总结
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment group C: HRS-1780 tablet Dose 3
Experimental
干预措施: HRS-1780 tablet (Drug)
Treatment group D: HRS-1780 tablet placebo
Placebo Comparator
干预措施: HRS-1780 tablet placebo (Drug)
Treatment group A: HRS-1780 tablet Dose 1
Experimental
干预措施: HRS-1780 tablet (Drug)
Treatment group B: HRS-1780 tablet Dose 2
Experimental
干预措施: HRS-1780 tablet (Drug)
结局指标
主要结局
Change from baseline in trough seated SBP at Week 12
时间窗: baseline and Week 12
次要结局
- Change from baseline in daytime and nighttime mean SBP measured by 24-hour ABPM at Week 12(baseline and Week 12)
- Change from baseline in daytime and nighttime mean DBP measured by 24-hour ABPM at Week 12(baseline and Week 12)
- Change from randomized withdrawal baseline (Week 44) in trough seated SBP at Week 52(Week 44 and Week 52)
- Proportion of participants with eGFR decline ≥ 30% during the treatment period(baseline and treatment period)
- Proportion of participants with serum potassium > 6.0 mmol/L during the treatment period(treatment period)
- Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean DBP at 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(treatment period)
- Proportion of participants achieving trough seated SBP < 130 mmHg at Week 12(Week 12)
- Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP at Week 12(baseline and Week 12)
- Change from baseline in trough seated DBP at Week 12(baseline and Week 12)
- Change from baseline in trough seated SBP at Week 8(baseline and Week 8)
- Proportion of participants achieving trough seated blood pressure < 140/90 mmHg at Week 12(Week 12)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
3 期
A Phase III Clinical Study on the Efficacy and Safety of HRS-1780 in the Treatment of Patients With Chronic Kidney DiseaseChronic Kidney DiseaseNCT07419828Shandong Suncadia Medicine Co., Ltd.5,386
尚未招募
2 期
SHR-1701 in Combination With Irinotecan Liposome (II) for Second-line Treatment of ESCC After ImmunotherapyESCCNCT07524374Zhigang Li33
招募中
2 期
SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric CancerNCT07464756The First Affiliated Hospital with Nanjing Medical University80
进行中（未招募）
2 期
Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute PancreatitisNCT07308392Fujian Shengdi Pharmaceutical Co., Ltd.119
尚未招募
2 期
SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLCNon-Small Cell Lung CancerNCT07489703Sun Yat-sen University30