A Study to Evaluate Efficacy and Safety of GW906 Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by One or Two Antihypertensive Medications
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of GW906 Injection (SAL0132) Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by One or Two Antihypertensive Medications
The purpose of this study is to evaluate the effect of GW906 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of GW906 as add-on therapy.
研究概览
详细说明
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy, safety, and pharmacokinetics of GW906 Injection used as add-on therapy in patients with hypertension not adequately controlled by one or two antihypertensive medications.
Participants are randomized to receive either GW906 Injection or placebo for 6 months.
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：Jianan Wang, Professor
- 电话号码：86-1599008651
- 邮箱：jiguangwang@rjh.com.cn
学习地点
-
-
Zhejiang
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Hangzhou、Zhejiang、中国、310009
- The Second Affiliated Hospital Zhejiang University School of Medicine
-
接触：
- Jianan Wang, Professor
- 电话号码：86-15990086511
- 邮箱：jiguangwang@rjh.com.cn
-
-
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:
- Age ≥ 18 years, of either sex.
- Treated hypertension on stable therapy with up to 1 or 2 antihypertensive medications. Stable therapy is defined as having no change in antihypertensive medication or dose within 4 weeks prior to randomization.
- Mean sitting systolic blood pressure (msSBP) ≥ 140 mmHg and < 180 mmHg at the randomization visit.
- Willing to participate in the study and provide written informed consent.
Exclusion Criteria:
- Secondary hypertension.
- orthostatic hypotension.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5× upper limit of normal (ULN); Total bilirubin > 1.5 × ULN; International normalized ratio (INR) > 2.0; Serum potassium > 5.0 mmol/L or < 3.5 mmol/L; eGFR≤30 mL/min/1.73m^2.
- Received an investigational agent within the last 3 months.
- Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus.
- History of any cardiovascular event within 12 months.
- History of intolerance to SC injection(s).
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 |
|---|---|
|
有源比较器：GW906
Subcutaneous injection. 24 weeks |
Subcutaneous injection. 24 weeks |
|
安慰剂比较：Placebo
Subcutaneous injection. 24 weeks |
Subcutaneous injection. 24 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 |
|---|---|---|
|
Change from baseline in mean sitting systolic blood pressure (msSBP) at Week 12
大体时间：Baseline and Month 3
|
msSBP will be measured in the office using a validated sphygmomanometer, with the participant seated and resting quietly for at least 5 minutes. The primary endpoint is the change from baseline, calculated as the Week 12 value minus the baseline value, expressed in mmHg |
Baseline and Month 3
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in mean sitting systolic blood pressure (msSBP) at Weeks 4, 8, and 24 of the double-blind period
大体时间：Baseline, Weeks 4, 8, and 24
|
Change from baseline, calculated as the Week 24 value minus the baseline value, expressed in mmHg |
Baseline, Weeks 4, 8, and 24
|
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
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.