ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11,000
- 试验地点
- 1,333
- 主要终点
- Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit)
研究概览
简要总结
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is 18 years or older for patients with established cardiovascular disease (CVD)
- •Is 55 years or older for patients with high risk for CVD
- •Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
- •Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic
排除标准
- •Has known history of secondary hypertension
- •Has symptomatic orthostatic hypotension
- •Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3×upper limit of normal (ULN)
- •Has total serum bilirubin >1.5×ULN
- •Has international normalized ratio (INR) >1.5
- •Has serum potassium >4.8 mEq/L
- •Has estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2
研究组 & 干预措施
Zilebesiran 300 mg
Participants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications.
干预措施: Zilebesiran (Drug)
Placebo
Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit)
时间窗: Up to approximately 5 years
次要结局
- Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6(Baseline and Month 6)
- Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke(Up to approximately 5 years)
- Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit)(Up to approximately 5 years)
- Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization(Up to approximately 5 years)
- Time to All-cause Death(Up to approximately 5 years)