A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Monthly Subcutaneous Administration of ION904 in Patients With Uncontrolled Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- Percent Change from Baseline in Plasma Angiotensinogen (AGT)
研究概览
简要总结
The purpose of this study is to evaluate the effect of ION904 on plasma angiotensinogen (AGT) in participants with uncontrolled hypertension.
详细描述
This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study. It will include up to approximately 48 participants with mild to moderate hypertension who have uncontrolled blood pressure (˃ 130 - ≤ 170 millimeters of mercury [mmHg] systolic) and have been on one or more anti-hypertensive medications for at least one month. Following an up to 4-week screening period, eligible participants will receive multiple doses of ION904 during a 13-week treatment period, followed by a 13-week post-treatment follow-up period.
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
- Triple (Participant, 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
- •Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), she uses a highly effective contraceptive method. Aged 18 - 75 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent
- •Body mass index (BMI) ≤ 45.0 kilograms per square meter (kg/m^2) at screening
- •History of uncontrolled hypertension (HTN) on one or more antihypertensive medications without changes in antihypertensive regimen within 4 weeks of screening and will be required to maintain this regimen throughout the Treatment Period
排除标准
- •History of secondary HTN including, but not limited to any of the following: renovascular HTN (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug induced HTN
- •Unstable/underlying known cardiovascular disease defined as:
- •Any history of congestive heart failure (New York Heart Association [NYHA] Class III-IV)
- •Any history of previous myocardial infarction, coronary revascularization, unstable or stable angina pectoris ˂ 6 months prior to screening
- •Any hemodynamically unstable atrial or ventricular arrhythmias
- •Significant uncorrected valvular heart disease
- •Any history of stroke or transient ischemic attack < 6 months prior to screening
- •A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening
研究组 & 干预措施
ION904
Up to 4 monthly doses of ION904 will be administered by subcutaneous (SC) injection.
干预措施: ION904 (Drug)
Placebo
Up to 4 monthly doses of placebo will be administered by SC injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Plasma Angiotensinogen (AGT)
时间窗: Baseline up to approximately 15 weeks
次要结局
- Change from Baseline in Seated Automated Office Systolic Blood Pressure (SBP)(Baseline up to approximately 15 weeks)
- Change from Baseline in Seated Automated Office Diastolic Blood Pressure (DBP)(Baseline up to approximately 15 weeks)