A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Adult Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 375
- 试验地点
- 196
- 主要终点
- Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP)
研究概览
简要总结
The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications.
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
- •History of cardiovascular (CV) disease, high CV risk, or estimated glomerular filtration rate (eGFR) ≥30 to <60 mL/min/1.73m^2
- •Mean seated office SBP ≥140 mmHg and ≤170 mmHg
- •24-hour mean SBP ≥130 mmHg and ≤170 mmHg assessed by ABPM
- •Must be on stable therapy with 2 to 4 classes of antihypertensive medications
排除标准
- •Secondary hypertension
- •Orthostatic hypotension
- •Proteinuria >3 g/day
- •Serum potassium >4.8 milliequivalents per liter (mEq/L)
研究组 & 干预措施
Zilebesiran
Participants will receive zilebesiran on Day 1 of the 6-month double-blind (DB) treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period.
干预措施: Zilebesiran (Drug)
Placebo
Participants will receive placebo on Day 1 of the 6-month DB treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP)
时间窗: Baseline and Month 3
次要结局
- Change from Baseline Over Time in Serum Angiotensinogen (AGT)(Baseline through Month 6)
- Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM(Baseline and Months 3 and 6)
- Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM(Baseline and Month 6)
- Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)(Baseline and Month 3)
- Change from Baseline at Month 6 in Mean Seated Office SBP(Baseline and Month 6)
- Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP(Baseline and Months 3 and 6)
- Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6(Month 6)
- Proportion of Patients with 24-hour Mean SBP assessed by ABPM <130 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6(Month 6)
- Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM(Baseline and Months 3 and 6)