Table of contents
- Trial overview
- Who can participate
- Study design and phase
- What is being measured
- Why this trial matters
Trial overview
The main trial in the source data is ZENITH, a Phase 3 study of ZILEBESIRAN in people with hypertension that is not adequately controlled and who have either established cardiovascular disease or high cardiovascular risk.[1]
This is an interventional study, which means researchers give a study treatment and compare outcomes between groups.[1]
Who can participate
The trial is designed for people with hypertension, which means high blood pressure, when it is not well controlled.[1]
Participants must also have either established cardiovascular disease or high cardiovascular risk, meaning they already have heart or blood vessel disease, or they have a higher chance of having one in the future.[1]
Study design and phase
The study is in Phase 3, which is a late stage of testing done in a large group of people to see how well a treatment works.[1]
The planned enrollment is 11,038 people, showing that this is a large trial meant to give strong evidence about the study treatment.[1]
The trial is authorised, which means it has been approved to move forward in the research process.[1]
What is being measured
The main endpoint, or main result, is the time to first occurrence of a composite endpoint.[1]
A composite endpoint combines several serious health events into one main measure. In this trial, those events are cardiovascular death, nonfatal heart attack, nonfatal stroke, and heart failure events such as a hospital stay for heart failure or an urgent heart failure visit.[1]
The brief summary says the study is testing whether ZILEBESIRAN, compared with placebo, reduces the risk of these major cardiovascular events.[1]
Why this trial matters
People with uncontrolled hypertension and cardiovascular disease are at higher risk for serious heart and blood vessel problems.[1]
This trial is important because it focuses on whether a study treatment can reduce major events that affect survival and quality of life, not just blood pressure numbers.[1]
