A Phase Ⅱ Clinical Trial of SYH2072 Tablets in Participants With Primary Aldosteronism
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2072 Tablets in Chinese Participants With Primary Aldosteronism
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to explore the efficacy and safety of SYH2072 tablets in Chinese participants with primary aldosteronism (PA) .
研究概览
详细说明
Participants diagnosed with primary aldosteronism will be randomly assigned to the SYH2072 group or the placebo group for a double-blind treatment period. SYH2072 (or matching placebo) will be administered once daily, with the dose up-titrated during the treatment period based on clinical response and tolerability.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名:Clinical Trials Information Group NA officer
- 电话号码:86-311-69085587
- 邮箱:ctr-contact@cspc.cn
学习地点
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Shandong
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Jinan、Shandong、中国、250000
- Qilu Hospital of Shandong University
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接触:
- 电话号码:86-531-82169603
- 邮箱:qlyygcp_ec@qiluhospital.cn
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 18 years or older; male or female.
- Documented diagnosis of primary aldosteronism (PA) before screening.
- Receiving stable antihypertensive therapy.
- Willing to discontinue mineralocorticoid receptor antagonists (MRA) or potassium-sparing diuretics.
- Mean seated office systolic blood pressure (SBP) ≥140 mmHg and <180 mmHg, and mean seated office diastolic blood pressure (DBP) <110 mmHg before randomization.
- Medication compliance of background antihypertensive therapy and placebo within 80%-120% during the run-in period.
- Voluntary participation in the study, with signed informed consent form.
Exclusion Criteria:
- Night shift workers.
- Known secondary causes of hypertension other than PA.
- Hypotension.
- Known hypersensitivity or allergic constitution.
- History of adrenal surgery, renal denervation, or similar procedures.
- History of adrenal insufficiency.
- Poorly controlled blood glucose, or GLP-1 receptor agonist not maintained at a stable dose for at least 4 weeks.
- Poorly controlled thyroid disease.
- Severe cardiovascular or cerebrovascular events within 6 months before screening.
- Severe arrhythmia within 6 months before screening.
- Severe heart failure within 6 months before screening.
- Major surgery within 6 months before screening.
- Severe gastrointestinal disease or history of gastrointestinal surgery.
- Clinically significant laboratory abnormalities.
- History of malignancy within 5 years.
- History of drug abuse within 5 years.
- Female participants who are pregnant, breastfeeding, or with a positive pregnancy test.
- Use of strong CYP3A4 inhibitors or strong CYP3A4 inducers within 4 weeks before screening.
- Participation in any drug or device clinical trial within 3 months before screening.
- Regular alcohol consumption within 90 days before screening.
- Any other reason that, in the opinion of the investigator, may prevent the participant from completing the study, or any condition for which the investigator considers enrollment inappropriate.
学习计划
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:Placebo group
Placebo |
Placebo administered orally, once daily (QD). |
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实验性的:SYH2072 group
SYH2072 Tablets |
SYH2072 tablets administered orally, once daily (QD) Placebo administered orally, once daily (QD). |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8
大体时间:week 8
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To evaluate the efficacy of SYH2072 tablets in improving blood pressure in trial participants with primary aldosteronism (PA) in China. |
week 8
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合作者和调查者
调查人员
- 学习椅:Yuguo Chen, Medical Doctor、Qilu Hospital of Shandong University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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