Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
This research study is investigating a new medication called zilebesiran. It's for people in the UK who have high blood pressure that isn't properly managed, even with current treatments. Participants either already have heart or blood vessel problems, or they are at particularly high risk of developing them. The main goal is to find out if zilebesiran can lower the chances of serious health issues such as a heart attack, stroke, or heart failure. The study will continue until enough of these events have happened to properly compare zilebesiran with a dummy treatment (placebo). This will help doctors understand if zilebesiran is a safe and effective new way to protect people from serious heart-related complications.
At a glance
What is this study about?
This study is about an investigational medicine called zilebesiran. This medicine might help people who have high blood pressure that isn't fully controlled by their current treatments. High blood pressure, if not properly managed, can significantly increase the risk of serious health problems like heart attacks, strokes, and heart failure. This is especially true for people who already have heart disease or are at a very high risk of getting it.
The main purpose of this study is to see if zilebesiran can reduce the risk of these serious heart-related events. Researchers will compare zilebesiran to a 'placebo' – which looks like the study drug but contains no active medicine. This comparison helps them understand if any improvements are genuinely due to the study drug. The study will continue until a certain number of these serious events have occurred across all participants, which allows for a fair and accurate comparison.
By taking part, you could contribute to developing new and potentially better ways to manage high blood pressure and protect against heart-related complications. The information gathered will be vital for doctors to make informed decisions about future treatments for patients like you.
Key takeaways
- This study investigates a new high blood pressure medicine called zilebesiran.
- It's for people with hard-to-control high blood pressure who also have heart disease or are at high risk.
- The main goal is to reduce heart attacks, strokes, and heart failure.
- Participants will receive either zilebesiran or a dummy drug (placebo).
- The study involves regular check-ups and health monitoring over an extended period.
Who may be eligible?
To join this study, you need to be an adult. If you already have existing heart or blood vessel problems, you must be 18 years old or older. If you're at high risk of developing these problems, you need to be 55 years old or older. You must also have high blood pressure that is currently being treated with at least two different blood pressure medicines, one of which must be a 'diuretic' (a water pill).
There are also some reasons why you might not be able to join. For example, if your high blood pressure is caused by another medical condition, or if you feel dizzy when standing up (orthostatic hypotension). Also, people with certain abnormal blood test results, such as problems with their liver, kidneys, or blood clotting, would not be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 or older with existing heart or blood vessel disease?
- Are you 55 or older with a high risk of developing heart or blood vessel disease?
- Do you have high blood pressure that is being treated with at least two medications, including a water pill (diuretic)?
- Do you not have high blood pressure caused by another medical condition?
- Do you not have serious liver, kidney, or blood clotting issues based on recent tests?
What does participation involve?
If you decide to take part in this study, you will be given either zilebesiran or a placebo (a dummy drug). You won't know which one you are receiving. You will continue to take your regular blood pressure medications as advised by the study team. You will have regular visits to the clinic for check-ups, which will include blood tests, blood pressure measurements, and other health assessments. The study itself is 'event-driven,' meaning it will continue until enough of the main heart-related events have happened across all participants, which could be several years. You will be closely monitored throughout this time.
Potential risks and benefits
Locations (742)
- Clinical Trial SiteVerified postcodeBirmingham, United States· Not yet recruiting
- Clinical Trial SiteVerified postcodeBirmingham, United States· Recruiting
- Clinical Trial SiteVerified postcodeFairhope, United States· Recruiting
- Clinical Trial SiteVerified postcodeFoley, United States· Recruiting
- Clinical Trial SiteVerified postcodeHuntsville, United States· Not yet recruiting
- Clinical Trial SiteVerified postcodeHuntsville, United States· Recruiting
- Clinical Trial SiteVerified postcodeSheffield, United States· Recruiting
- Clinical Trial SiteVerified postcodeChandler, United States· Recruiting
- Clinical Trial SiteVerified postcodeGilbert, United States· Recruiting
- Clinical Trial SiteVerified postcodeGlendale, United States· Not yet recruiting
- Clinical Trial SiteVerified postcodeMesa, United States· Not yet recruiting
- Clinical Trial SiteVerified postcodePhoenix, United States· Recruiting
Common questions
What is zilebesiran?
Zilebesiran is a new, investigational medicine being tested to see if it can help control high blood pressure and prevent serious heart problems.
What is a placebo?
A placebo is a 'dummy' treatment that looks exactly like the study medicine but contains no active drug. It helps researchers compare if the new drug is truly effective.
Why is this study important for people with high blood pressure?
It's important because it aims to find new and better ways to manage high blood pressure, especially for those at high risk, to reduce their chances of serious heart conditions.
How long will the study last?
The study will continue until enough key medical events have occurred among all participants, which could mean it lasts for several years.
Will I still take my regular blood pressure medicines?
Yes, you will continue to take your usual blood pressure medications as advised by the study doctors, alongside either zilebesiran or the placebo.
How to find out more
Clinical Trial Information Line
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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