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Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

NCT07181109

RecruitingPhase 3

Sponsor: Alnylam Pharmaceuticals

Conditions: High Risk Cardiovascular Disease, Hypertension, High Cardiovascular Risk

Interventions: Zilebesiran, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
Locations (995)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Fairhope, Alabama, United States
  • Foley, Alabama, United States
  • Huntsville, Alabama, United States
  • Huntsville, Alabama, United States
  • Sheffield, Alabama, United States
  • Chandler, Arizona, United States
  • Gilbert, Arizona, United States
  • Glendale, Arizona, United States
  • Mesa, Arizona, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Sun City, Arizona, United States
  • Sun City West, Arizona, United States
  • Tempe, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Yuma, Arizona, United States
  • Little Rock, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Beverly Hills, California, United States
  • Chula Vista, California, United States
  • Covina, California, United States
  • Escondido, California, United States
  • Glendale, California, United States
  • Huntington Beach, California, United States
  • La Jolla, California, United States
  • Lancaster, California, United States
  • Long Beach, California, United States
  • + 965 more on CT.gov