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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
375
Zilebesiran administered by subcutaneous (SC) injection
Placebo administered by SC injection
Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP)
Time frame: Baseline and Month 3
Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: Baseline and Month 3
Change from Baseline at Month 6 in Mean Seated Office SBP
Time frame: Baseline and Month 6
Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM
Time frame: Baseline and Month 6
Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6
Time frame: 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
Time frame: 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
Time frame: Baseline and Months 3 and 6
Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP
Time frame: Baseline and Months 3 and 6
Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM
Time frame: Baseline and Months 3 and 6
Change from Baseline Over Time in Serum Angiotensinogen (AGT)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Trial Site
Alexander City, Alabama, United States
Clinical Trial Site
Daphne, Alabama, United States
Clinical Trial Site
Foley, Alabama, United States
Clinical Trial Site
Huntsville, Alabama, United States
Clinical Trial Site
Huntsville, Alabama, United States
Clinical Trial Site
Montgomery, Alabama, United States
Clinical Trial Site
Gilbert, Arizona, United States
Clinical Trial Site
Phoenix, Arizona, United States
Clinical Trial Site
Sun City, Arizona, United States
Clinical Trial Site
Tempe, Arizona, United States
...and 185 more locations
Time frame: Baseline through Month 6