A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GW906 (SAL0132) Injection in Patients With Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 319
- 试验地点
- 1
- 主要终点
- Change from baseline in mean sitting systolic blood pressure (msSBP) at Week 12
研究概览
简要总结
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.
详细描述
This study consists of two parts, Part A and Part B. Part A is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy, safety, and pharmacokinetics of GW906 Injection in patients with essential hypertension.
Part B is a multicenter, open-label, long-term study designed to evaluate the long-term safety and efficacy of GW906 Injection in patients with essential hypertension.
In Part A, participants are randomized to receive either GW906 Injection or placebo for 6 months. Participants who complete Part A are eligible to enter Part B and will receive GW906 Injection.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 75 years, of either sex.
- •Mean sitting systolic blood pressure (msSBP) ≥ 140 mmHg and < 180 mmHg at screening.
- •Willing to participate in the study and provide written informed consent.
排除标准
- •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^
- •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).
研究组 & 干预措施
Placebo
Subcutaneous injection
干预措施: Placebo (Drug)
GW906
Subcutaneous injection
干预措施: GW906 (Drug)
结局指标
主要结局
Change from baseline in mean sitting systolic blood pressure (msSBP) at Week 12
时间窗: 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
次要结局
- Change from baseline in mean sitting systolic blood pressure (msSBP) at Weeks 4, 8, and 24 of the double-blind period(Baseline, Weeks 4, 8, and 24)