A study to learn how safe nurandociguat is when taken with sildenafil in men with arterial hypertension.
This study is for men who have high blood pressure, sometimes called arterial hypertension. Researchers want to find out more about how safe a new medicine, nurandociguat, is when taken alongside another common medicine called sildenafil, which many might know as Viagra. This is a very early stage of research, sometimes called a Phase I study. This means it's mainly about understanding how the new medicine works in the human body, especially when combined with sildenafil. The goal is to see if nurandociguat and sildenafil can be safely used together. The study involves men aged 18 and over, and it's important for developing new treatments safely in the future.
At a glance
What is this study about?
This study is looking into a new medicine called nurandociguat. The main aim is to understand how safe it is when taken at the same time as sildenafil. Sildenafil is a medicine that many people might know as Viagra, which is often used for certain heart or blood vessel conditions, or for erectile dysfunction. This research is specifically for men who have high blood pressure, also known as arterial hypertension. High blood pressure is a common condition where the force of blood against your artery walls is too high, which can lead to serious health problems if not managed.
This is a very early stage of research, often called a Phase 1 study. At this point, scientists are mainly focused on understanding how a new medicine behaves in the body. They want to check things like how much of the medicine gets into the bloodstream, how quickly it leaves the body, and importantly, if it causes any unwanted side effects, especially when taken with another medicine like sildenafil. These early studies are crucial for making sure that any new medicine has the potential to be safe for people to use.
The information gathered from studies like this helps doctors and scientists decide if a new medicine is safe enough to be tested in larger groups of people for longer periods. It's all about making sure that future medicines are not only helpful but also as safe as possible for patients. Even though the study mentions chronic kidney disease in the 'conditions' section, the primary focus seems to be on men with high blood pressure and how the two medicines interact there, rather than directly treating kidney disease with this combination at this very early stage.
Key takeaways
- This study evaluates the safety of a new medicine, nurandociguat, with sildenafil.
- It's for men aged 18 and over who have high blood pressure.
- It's a Phase I study, focusing on how the medicines interact and their side effects.
- Participation involves medical check-ups and close health monitoring.
- You can withdraw from the study at any time.
- This research helps develop safer medicines for the future.
Who may be eligible?
To join this study, you need to be a man and be at least 18 years old. There isn't an upper age limit mentioned, so older men can also be considered.
The study is specifically looking for men who have high blood pressure, which doctors call arterial hypertension. While chronic kidney disease is listed as a condition, it seems the main focus for eligibility is having high blood pressure.
Because this is an early study looking at how two medicines work together, there will likely be other health checks to make sure it's safe for you to take part. For example, the study would need to ensure that taking both nurandociguat and sildenafil together won't put your health at risk.
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 a man?
- Are you 18 years old or older?
- Do you have high blood pressure (arterial hypertension)?
- Are you willing to potentially take sildenafil?
- Are you generally healthy enough to participate in a study looking at new medicines?
What does participation involve?
If you take part in this study, you would likely have several visits to a clinic or hospital. During these visits, doctors and nurses will monitor your health closely. This will involve regular check-ups, which might include blood tests, urine samples, measuring your blood pressure and heart rate, and answering questions about how you are feeling. You will be given the study medicine, nurandociguat, along with sildenafil, and closely watched for any side effects or changes in your health.
The study is designed to understand how safe these medicines are when taken together, so you can expect detailed observations, especially when you first start taking the medicines. The total amount of time you would spend participating in the study, including the number of visits and how long each visit lasts, will be fully explained to you before you agree to take part. There will also be follow-up appointments after you stop taking the medicines to ensure you remain well.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is 'arterial hypertension'?
Arterial hypertension is the medical term for high blood pressure. It means the force of your blood against your artery walls is consistently too high.
What is 'sildenafil'?
Sildenafil is a medicine that is commonly known by the brand name Viagra. It's used for conditions involving blood vessels, including erectile dysfunction.
Why is this called a 'Phase I' study?
A 'Phase I' study is a very early stage of research. Its main goal is to check how safe a new medicine is in humans and how it works in the body, rather than whether it can cure a disease.
Will I get access to the new medicine after the study?
Not necessarily. This is an early study, and the medicine is not yet approved for general use. Access after the study is usually not guaranteed.
Do I have to pay to take part?
No, you do not have to pay to take part in a clinical trial. All study-related care and medicines are provided free of charge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.