A Phase II Clinical Trial to Evaluate the Efficacy and Safety of QLS1410 Tablets in Patients With Uncontrolled Hypertension Who Are Receiving One or More Background Drug Treatments
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of QLS1410 Tablets in Patients With Uncontrolled Hypertension (Including Resistant Hypertension) Who Are Being Treated With One or More Antihypertensive Medications.
The goal of this clinical trial is to evaluate the efficacy and safety of multiple dose strengths of QLS1410 in patients with uncontrolled hypertension.
研究概览
详细说明
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of QLS1410 tablets in patients with uncontrolled hypertension. Approximately 260 patients will be randomized in a 1:1:1:1 ratio into 1 of the 4 treatment groups. The study will consist of the following 4 periods: A Screening Period of up to 2 weeks, A Run -in Period of 2 weeks, A Double-Blind Treatment Period of 12 weeks and A Follow-Up Period of 1 weeks.
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:Wang Jiguang, M.D
- 电话号码:13764189476
- 邮箱:jiguangw@163.com
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:
- Male or female participants must be ≥ 18 years old.
- Mean seated SBP ≥ 140 mmHg at Screening and at Baseline.
- Fulfil the following requirements: have a stable regimen (≥ 4 weeks) of one or more antihypertensive medications at the maximum tolerated dose as determined by the investigator.
Exclusion Criteria:
- Mean seated systolic blood pressure (SBP)≥ 180 mmHg.
- Mean seated diastolic blood pressure (DBP)≥ 110 mmHg.
- Estimated glomerular filtration rate \< 45 mL/min/1.73m2.
- Serum potassium (K+) level \<3.5 and ≥ 5.0 mmol/L.
- Concomitant treatment with both ACEI and ARB.
- Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled hyperthyroidism, uncontrolled hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
- NYHA functional heart failure class IV at Screening.
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:安慰剂
|
Matching placebo tablet administered orally, once daily (QD). |
|
实验性的:Dose 2 of QLS1410
|
Patients will take oral tablets of QLS1410 once daily (QD) for 12 weeks. |
|
实验性的:Dose 3 of QLS1410
|
Patients will take oral tablets of QLS1410 once daily (QD) for 12 weeks. |
|
实验性的:ose 1 of QLS1410
|
Patients will take oral tablets of QLS1410 once daily (QD) for 12 weeks |
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 |
|---|---|---|
|
Primary efficacy endpoint
大体时间:At week 12
|
Change From Baseline in Mean Seated Systolic BP (SBP) |
At week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety endpoint
大体时间:12 weeks
|
Number of Participants With Any Adverse Events |
12 weeks
|
|
Efficacy endpoint
大体时间:At week 4 and 8
|
Change From Baseline in Mean Seated Systolic BP (SBP) |
At week 4 and 8
|
合作者和调查者
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
与本研究相关的术语
其他研究编号
- QLS1410-206
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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