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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522335-34-00 | EU Trial (CTIS) Number |
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This study is designed to find out how safe nitroglycerin is and how it affects the body when it is taken together with another medicine called nurandociguat in people who have coronary artery disease (CAD). CAD is a condition where the arteries that supply blood to the heart become narrowed or blocked, often causing chest pain or even heart attacks. Many people with CAD also have chronic kidney disease (CKD), a long-term condition where the kidneys do not work as well as they should.
People with CAD often use nitroglycerin to help improve blood flow to the heart. Nurandociguat is a new medicine being studied to help people with CKD by widening blood vessels and improving blood flow. Both nitroglycerin and nurandociguat work in similar ways in the body, so taking them together could have a stronger effect on blood vessels. This might lead to a sudden drop in blood pressure or other side effects. The main goal of this study is to learn how safe it is to use nitroglycerin and nurandociguat together, and to understand how they interact in the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurandociguat Arm | Experimental | Participants receive nurandociguat plus 0.4 mg nitroglycerin spray |
|
| Placebo Arm | Placebo Comparator | Participants receive placebo matching nurandociguat plus 0.4 mg nitroglycerin spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroglycerin spray | Drug | 0.4 mg sublingual spray |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events per treatment group | The incidence of treatment-emergent adverse events will be summarized. | Up to 7 days after the last treatment, for a total of up to about 7 weeks per participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Contact | 4930300139003 | clinical-trials-contact@bayer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comac Medical | Phase I Clinical Research Unit | Sofia | Sofia City Province | 1000 | Bulgaria | ||
| Universitätsklinikum Heidelberg - Zentrum für Innere Medizin, Abteilung Klinische Pharmakologie und Pharmakoepidemologie |
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.
As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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Only sponsor personnel will be kept unblinded to allow for rapid safety signal detection.
| Nurandociguat |
| Drug |
Tablet, oral |
|
| Placebo | Drug | Tablet matching nurandociguat, oral |
|
| Heidelberg |
| Baden-Wurttemberg |
| 69120 |
| Germany |
| UK Bonn Institut für Klinische Chemie und Klinische Pharmakologie, Phase I Einheit und Arzneimitteltherapiesicherheit | Bonn | North Rhine-Westphalia | 53127 | Germany |
| SocraTec R&D Erfurt-Clinical Pharmacology Unit | Erfurt | Thuringia | 99084 | Germany |
| Deutsches Herzzentrum der Charité (DHZC) - Klinik für Kardiologie, Angiologie und Intensivmedizin CVK | Berlin | 13353 | Germany |