Loading clinical trials...

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 | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

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

A Randomized, Placebo-controlled, Single Blind Drug-drug Interaction Study to Investigate the Influence of 0.4 mg Nitroglycerin Spray on the Safety, Tolerability and Pharmacodynamic Effects of Nurandociguat in Participants With Stable Coronary Artery Disease.

NCT07431294•Bayer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must be 40 to 80 years of age inclusive at the time of signing the informed consent
•Participants with stable CAD defined by coronary artery stenosis in any of the 3 main coronary vessels greater than 50 percent documented by coronary angiography within the last 36 months or history of myocardial infarction more than 6 months prior to the screening visit
•Estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL per min per 1.73 m2 at screening
•Body weight greater than or equal to 60 kg and body mass index within the range greater than or equal to 18 and less than or equal to 36 kg per m2 at screening.

Exclusion Criteria

•Ejection fraction less than 30 percent at screening as determined by echocardiography
•Progressive angina with symptoms of worsening of angina in the 3 months prior to the first screening examination and/or interventions such as revascularization by percutaneous coronary intervention and or coronary artery bypass graft during the last 3 months
•Documented current relevant coronary stenosis greater than or equal to 90 percent in any of the main 3 coronary vessels without bypass graft
•Significant valvular heart disease with moderate or severe aortic stenosis or any other significant stenosis any other moderate or severe valvular failures hypertrophic obstructive cardiomyopathy
•Symptomatic carotid stenosis or transient ischemic attack or stroke within 3 months prior to the first screening examination or patients with stroke at more than 3 months prior to the first screening examination with significant residual neurologic involvement
•Atrial fibrillation pacemaker defibrillator atrial ventricular block II and III
•History of sustained ventricular tachycardia or ventricular fibrillation within 12 months prior first screening visit
•History of CNS diseases such as seizures neurodegenerative diseases
•Lung diseases such as COPD GOLD stage 2-4 pulmonary arterial hypertension or asthma
•Medical disorder condition or history of such that would impair the participant's ability to participate or complete the study in the opinion of the investigator.

Locations (5)

Comac Medical | Phase I Clinical Research Unit

Sofia, Sofia City Province, Bulgaria

Deutsches Herzzentrum der Charité (DHZC) - Klinik für Kardiologie, Angiologie und Intensivmedizin CVK

Berlin, Germany

UK Bonn Institut für Klinische Chemie und Klinische Pharmakologie, Phase I Einheit und Arzneimitteltherapiesicherheit

Bonn, Germany

SocraTec R&D Erfurt-Clinical Pharmacology Unit

Erfurt, Germany

Universitätsklinikum Heidelberg - Zentrum für Innere Medizin, Abteilung Klinische Pharmakologie und Pharmakoepidemologie

Heidelberg, Germany

Key Dates

Start Date

April 7, 2026

Primary Completion Date

December 4, 2026

Completion Date

December 4, 2026

Last Updated

March 4, 2026

Enrollment

ESTIMATED participants

Conditions

Stable Coronary Artery Disease

Interventions

Nitroglycerin spray

DRUG

Nurandociguat

DRUG

Placebo

DRUG

Contacts

Therapeutic Area Head

CONTACT

4930300139003 clinical-trials-contact@bayer.com

Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)

NCT07195149

Chronic Coronary SyndromeStable Coronary Artery Disease CAD

View study

COMPLETED

Volatilome and Single-Lead Electrocardiogram Optimize Ischemic Heart Disease Diagnosis Using Machine Learning Models

NCT06181799

Coronary Artery DiseaseIschemic Heart Disease+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)

Volatilome and Single-Lead Electrocardiogram Optimize Ischemic Heart Disease Diagnosis Using Machine Learning Models

Angina Prevalence and Provider Evaluation of Angina Relief

Syndrome Differentiation in the Management of Chronic Stable Coronary Artery Disease (SCAD) to Improve Quality

A Pharmacodynamic Study With Ticagrelor in African American Patients