EUCTR2021-003776-13-EE进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication - KARDIA-2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age 18 to 75 years, inclusive, at time of initial informed consent
- •-24-hour mean SBP=130 mmHg and =160 mmHg by ABPM at Run-in Visit 2 after at least 4 weeks of run-in
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •-Secondary hypertension, orthostatic hypotension
- •-Elevated potassium >5 mEq/L
- •-eGFR of =30 mL/min/1.73m2
- •-Received an investigational agent within the last 30 days
- •-Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus
- •-History of any cardiovascular event within 6 months prior to randomization
- •-History of intolerance to subcutaneous injection(s)
研究者
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