Recruiting NCT07181109

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

Phase III Interventional High Risk Cardiovascular Disease Hypertension High Cardiovascular Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Zilebesiran, Placebo.
Who it may be relevant to: Registry conditions: High Risk Cardiovascular Disease, Hypertension, High Cardiovascular Risk. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +29
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

Overview

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.

Interventions

Drug Zilebesiran
Zilebesiran will be administered SC
Drug Placebo
Placebo will be administered SC

Primary outcome measures

Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit) [Time frame: Up to approximately 5 years]

Secondary outcome measures (5)

Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6 [Time frame: Baseline and Month 6]
Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke [Time frame: Up to approximately 5 years]
Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit) [Time frame: Up to approximately 5 years]
Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization [Time frame: Up to approximately 5 years]
Time to All-cause Death [Time frame: Up to approximately 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment