Un estudio para conocer la seguridad de la nitroglicerina y sus efectos en el organismo cuando se administra junto con nurandociguat en personas con enfermedad arterial coronaria
Estudio aleatorizado, controlado con placebo, de interacción medicamentosa simple ciego para investigar la influencia de 0,4 mg de aerosol de nitroglicerina en la seguridad, tolerabilidad y efectos farmacodinámicos de Nurandociguat en participantes con enfermedad arterial coronaria estable.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Therapeutic Area Head
- Número de teléfono: 4930300139003
- Correo electrónico: clinical-trials-contact@bayer.com
Ubicaciones de estudio
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Berlin, Alemania, 13353
- Deutsches Herzzentrum der Charité (DHZC) - Klinik für Kardiologie, Angiologie und Intensivmedizin CVK
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Alemania, 69120
- Universitätsklinikum Heidelberg - Zentrum für Innere Medizin, Abteilung Klinische Pharmakologie und Pharmakoepidemologie
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Alemania, 53127
- UK Bonn Institut für Klinische Chemie und Klinische Pharmakologie, Phase I Einheit und Arzneimitteltherapiesicherheit
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Thuringia
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Erfurt, Thuringia, Alemania, 99084
- SocraTec R&D Erfurt-Clinical Pharmacology Unit
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Sofia City Province
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Sofia, Sofia City Province, Bulgaria, 1000
- Comac Medical | Phase I Clinical Research Unit
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Nurandociguat Arm
Participants receive nurandociguat plus 0.4 mg nitroglycerin spray |
0.4 mg sublingual spray Tablet, oral |
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Comparador de placebos: Placebo Arm
Participants receive placebo matching nurandociguat plus 0.4 mg nitroglycerin spray |
0.4 mg sublingual spray Tablet matching nurandociguat, oral |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with treatment-emergent adverse events per treatment group
Periodo de tiempo: Up to 7 days after the last treatment, for a total of up to about 7 weeks per participant
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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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 22597
- 2025-522335-34-00 (Ctis)
- 2025 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .