Not yet recruitingPHASE1INTERVENTIONAL

A Study to Learn About How Safe Nitroglycerin is and How it Affects the Body When Taken Along With Nurandociguat in People With Coronary Artery Disease

This study aims to understand how safe it is to take nitroglycerin, a common medicine for heart artery disease, alongside a new medicine called nurandociguat. Nurandociguat is still being studied to help people with kidney disease by relaxing blood vessels. Both medicines work similarly by widening blood vessels, and taking them together might lead to stronger effects, like a drop in blood pressure. We need to find out if combining them is safe and how they interact. This is for people aged 40 to 80 who have stable heart artery disease.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

Bayer

Enrolment target

Start

01 Oct 2026

Estimated completion

07 May 2027

Stable Coronary Artery Disease

What is this study about?

You might know that nitroglycerin is often used to help people with coronary artery disease (CAD) – that's when the arteries supplying blood to your heart become narrowed or blocked. This can cause chest pain or even heart attacks. Many people with CAD also have chronic kidney disease (CKD), where their kidneys don't work as well as they should.

Now, there's a new medicine called nurandociguat being studied. It's hoped that nurandociguat could help people with CKD by also widening blood vessels and improving blood flow. The interesting thing is that both nitroglycerin and nurandociguat work in a similar way in your body. Because of this, taking them together might have a stronger effect on your blood vessels than either medicine alone.

The main aim of this study is to carefully look at how safe it is to use both nitroglycerin and nurandociguat at the same time. We also want to understand exactly how these medicines interact with each other in your body. For example, a stronger effect on blood vessels could lead to a sudden drop in blood pressure or other unexpected side effects. By doing this study, we hope to gather important information that will help doctors know if it's safe to give these two medicines together in the future.

Key takeaways

This study is testing the safety of combining two medicines.
It's for people with stable heart artery disease.
One medicine is a common heart spray, the other is new for kidney health.
Both medicines widen blood vessels, so their combined effect is being studied.
Understanding these interactions is important for future treatments.

Who may be eligible?

This study is looking for men and women between the ages of 40 and 80. You would need to have stable coronary artery disease, which means your heart arteries are narrowed or blocked, and this has been stable for a while. Doctors would need to have checked your heart arteries in the last three years, or you would have had a heart attack more than six months ago.

Your kidneys also need to be working reasonably well, measured by a specific kidney function test. You would also need to be within a certain weight range.

There are some reasons why you couldn't take part. For example, if your heart isn't pumping blood well, if you've recently had worsening chest pain or heart procedures, or if you have certain other heart conditions like severe valve problems or irregular heart rhythms. People with recent strokes, certain brain conditions, or severe lung problems like COPD or asthma would also not be able to join. The study team will check all these details carefully to make sure it's safe for you 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 between 40 and 80 years old?
Do you have stable coronary artery disease?
Has your heart artery condition been stable for a while?
Are your kidneys working reasonably well?
Are you within a certain weight range (doctors will check this)?

Answer every question to see your result.

What does participation involve?

This is a Phase 1 study, which usually means it's one of the first times a new medicine (or combination of medicines) is being tested in people. The main focus will be on understanding how your body handles the medicines and if they are safe when taken together. You would likely receive either nitroglycerin spray, nurandociguat, or a placebo (a dummy medicine with no active ingredients). The study team will tell you exactly what is involved, including how many visits you would need to make, what tests you would have (like blood tests or heart checks), how long you'd take the medicine, and how long they would follow up with you after you stop taking the study medicines. The total duration of your involvement in the study would be clearly explained.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The main benefit here is contributing to medical knowledge that could help future patients with heart and kidney conditions. You might also get closely monitored healthcare during the study. However, there's always a risk of side effects from the medicines, including things like a drop in blood pressure, or that the medicines won't help you personally. You are entirely free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (5)

Comac Medical | Phase I Clinical Research Unit
Verified postcode
Sofia, Bulgaria
Deutsches Herzzentrum der Charité (DHZC) - Klinik für Kardiologie, Angiologie und Intensivmedizin CVK
Verified postcode
Berlin, Germany
UK Bonn Institut für Klinische Chemie und Klinische Pharmakologie, Phase I Einheit und Arzneimitteltherapiesicherheit
Verified postcode
Bonn, Germany
SocraTec R&D Erfurt-Clinical Pharmacology Unit
Verified postcode
Erfurt, Germany
Universitätsklinikum Heidelberg - Zentrum für Innere Medizin, Abteilung Klinische Pharmakologie und Pharmakoepidemologie
Verified postcode
Heidelberg, Germany

Common questions

What is Coronary Artery Disease (CAD)?

CAD is when the blood vessels that supply your heart become narrowed or blocked, which can cause chest pain or heart attacks.

What is nurandociguat?

Nurandociguat is a new medicine being studied. It aims to help people by widening blood vessels, particularly for those with kidney disease.

What is 'Phase 1' study?

A Phase 1 study is usually one of the first times a new medicine, or a combination of medicines, is tested in people. The main goal is to check safety and how the body handles the medicine.

Will I definitely get the new medicine?

You might get the new medicine, an existing medicine (nitroglycerin), or a placebo (a dummy medicine), as part of the study design. You won't know which you are getting.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Therapeutic Area Head

clinical-trials-contact@bayer.com 4930300139003 Official trial record

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