Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease (ZENITH)
Actively Recruiting
About This Study
High blood pressure affects 45% of adults worldwide and is the biggest risk factor for cardiovascular disease. Despite there being many medications to treat high blood pressure approximately half of these patients had not achieved guideline recommended blood pressure goals. Clinical data from phase 1 and 2 studies have proven that a new medication Zilebesiran has the potential of lowering blood pressure with less frequent administration. (Every 6 months) Reducing blood pressure significantly reduces cardiovascular risks. The goal of this study is to evaluate if Zilebesiran verses Placebo reduces the risk of cardiovascular death, nonfatal heart attacks, strokes or heart failure events.
Who Can Participate?
✓ 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