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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to learn about the safety of BAY 3283142 in people with mild to moderate high blood pressure

This research study is testing a new medicine, BAY 3283142, in people who have mild to moderate high blood pressure and chronic kidney disease. This is one of the very first studies in humans, so the main goal is to understand how safe the medicine is at different doses and what kind of side effects it might cause. It's an important step in developing new treatments. Researchers will carefully watch participants to learn how their bodies react to the new medicine. This study will help us understand if BAY 3283142 could be a helpful treatment option in the future for people living with these conditions.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Bayer AG
Enrolment target
72
Start
30 Jul 2024

What is this study about?

This study is about a new medicine called BAY 3283142. Researchers want to learn more about how it works and, most importantly, if it’s safe for people to take. They are testing it in adults who have two health conditions: slightly high blood pressure (which doctors call mild to moderate hypertension) and ongoing kidney problems (chronic kidney disease).

Because this is one of the first times this new medicine is being given to people, the main focus is on safety. The research team will be looking very closely at how participants react to the medicine, what side effects they might experience, and if different doses cause different reactions. This helps them understand the best and safest way to use the medicine.

Finding new medicines for conditions like high blood pressure and kidney disease is really important. Studies like this are the first step in discovering if a new medicine could eventually become a treatment that helps many people feel better and live healthier lives. Every new medicine goes through these careful safety checks.

Key takeaways

  • This study is testing a brand-new medicine called BAY 3283142.
  • It's for adults with mild to moderate high blood pressure and ongoing kidney problems.
  • The main goal is to check how safe the medicine is and if it causes any side effects.
  • This is an early-stage study, meaning it's one of the first times people are taking this medicine.
  • Participation involves regular clinic visits for health checks and samples.
  • You can stop taking part in the study whenever you choose.

Who may be eligible?

This study is looking for volunteers who are adults, meaning they must be 18 years old or older. There is no upper age limit for taking part.

Both men and women can join this study. You will need to have a diagnosis of mild to moderate high blood pressure, as well as chronic kidney disease.

Other specific health requirements, and possibly some conditions that would prevent you from joining, would be discussed in detail by the study team if you are interested.

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.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of mild to moderate high blood pressure?
  3. Do you also have a diagnosis of chronic kidney disease?
  4. Are you able to attend regular clinic appointments as required by the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new study medicine, BAY 3283142. The study team will explain the exact schedule of visits, but generally, you can expect to visit the clinic a number of times over a period of weeks or months. During these visits, the study team will carry out health checks, take blood and urine samples, and ask you about how you are feeling and any side effects you might be having. This will help them understand how your body is reacting to the medicine. You will be closely monitored throughout your time in the study, and there will also be follow-up appointments after you stop taking the medicine to make sure you are well. The total length of time you would be involved in the study would be explained before you agree to take part.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a new medicine that could potentially help your high blood pressure or kidney condition, though this is not guaranteed as it's a very early-stage study. You would also contribute valuable information that could help others in the future. However, there are also risks. Because this is a new medicine, there might be unknown side effects or the medicine might not work for you. You will be closely monitored for any problems. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Germany

Common questions

What is BAY 3283142?

It's a new medicine being tested for people with high blood pressure and kidney disease. This study is one of the first times it's being given to humans, focusing on its safety.

Why is this study important?

It's the very first step in understanding if this new medicine is safe and if it could eventually help people with high blood pressure and kidney problems in the future.

Will I get better if I join this study?

While the medicine aims to help, there's no guarantee it will improve your condition at this early stage. The main goal is to understand safety, not necessarily treatment effectiveness yet.

What does chronic kidney disease mean?

It means your kidneys have been damaged and are not working as well as they should. It's a long-term condition that can get worse over time.

Will I have to pay to be in the study?

No, you will not have to pay to participate. All study-related care and medication are provided at no cost, and some studies may even offer help with travel costs.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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