Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
Recruiting · NCT07181109 · Interventional (participants receive a specific treatment) · Lead sponsor: Alnylam Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboZilebesiran
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 37 US states.
- Clinical Trial Site - Birmingham, Alabama, United States
- Clinical Trial Site - Birmingham, Alabama, United States
- Clinical Trial Site - Birmingham, Alabama, United States
- Clinical Trial Site - Fairhope, 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 - Sheffield, Alabama, United States
- Clinical Trial Site - Chandler, Arizona, United States
- Clinical Trial Site - Gilbert, Arizona, United States
- Clinical Trial Site - Glendale, Arizona, United States
- Clinical Trial Site - Mesa, Arizona, United States
- Clinical Trial Site - Phoenix, Arizona, United States
- Clinical Trial Site - Phoenix, Arizona, United States
- Clinical Trial Site - Sun City, Arizona, United States
- Clinical Trial Site - Sun City West, Arizona, United States
- Clinical Trial Site - Tempe, Arizona, United States
- Clinical Trial Site - Tucson, Arizona, United States
- Clinical Trial Site - Tucson, Arizona, United States
- Clinical Trial Site - Tucson, Arizona, United States
- Clinical Trial Site - Yuma, Arizona, United States
- Clinical Trial Site - Little Rock, Arkansas, United States
- Clinical Trial Site - Little Rock, Arkansas, United States
- Clinical Trial Site - Little Rock, Arkansas, United States
- Clinical Trial Site - Beverly Hills, California, United States
- Clinical Trial Site - Chula Vista, California, United States
- Clinical Trial Site - Covina, California, United States
- Clinical Trial Site - Escondido, California, United States
- Clinical Trial Site - Glendale, California, United States
- Clinical Trial Site - Huntington Beach, California, United States
- Clinical Trial Site - La Jolla, California, United States
- Clinical Trial Site - Lancaster, California, United States
- Clinical Trial Site - Long Beach, California, United States
- Clinical Trial Site - Lynwood, California, United States
- Clinical Trial Site - Newhall, California, United States
- Clinical Trial Site - Northridge, California, United States
- Clinical Trial Site - Pasadena, California, United States
- Clinical Trial Site - San Diego, California, United States
- Clinical Trial Site - San Dimas, California, United States
- Clinical Trial Site - San Ramon, California, United States
- Clinical Trial Site - Tarzana, California, United States
- Clinical Trial Site - Toluca Lake, California, United States
- Clinical Trial Site - Torrance, California, United States
- Clinical Trial Site - Tustin, California, United States
- Clinical Trial Site - Vista, California, United States
- Clinical Trial Site - Walnut Creek, California, United States
- Clinical Trial Site - Wheat Ridge, Colorado, United States
- Clinical Trial Site - Bridgeport, Connecticut, United States
- Clinical Trial Site - Waterbury, Connecticut, United States
- Clinical Trial Site - Boca Raton, Florida, United States
- Clinical Trial Site - Brandon, Florida, United States
- Clinical Trial Site - Fleming Island, Florida, United States
- Clinical Trial Site - Fort Lauderdale, Florida, United States
- Clinical Trial Site - Hialeah, Florida, United States
- Clinical Trial Site - Hialeah, Florida, United States
- Clinical Trial Site - Hollywood, Florida, United States
- Clinical Trial Site - Homestead, Florida, United States
- Clinical Trial Site - Jacksonville, Florida, United States
- Clinical Trial Site - Jacksonville, Florida, United States
- Clinical Trial Site - Jacksonville, Florida, United States
Showing 60 of 1105 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →