Een studie om te onderzoeken hoe veilig nitroglycerine is en hoe het het lichaam beïnvloedt wanneer het samen met nurandociguat wordt ingenomen bij mensen met coronairlijden
Een gerandomiseerde, placebo-gecontroleerde, enkelblinde geneesmiddelinteractiestudie om de invloed van 0,4 mg nitroglycerinespray op de veiligheid, verdraagbaarheid en farmacodynamische effecten van Nurandociguat te onderzoeken bij deelnemers met stabiele coronaire hartziekte.
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Therapeutic Area Head
- Telefoonnummer: 4930300139003
- E-mail: clinical-trials-contact@bayer.com
Studie Locaties
-
-
Sofia City Province
-
Sofia, Sofia City Province, Bulgarije, 1000
- Comac Medical | Phase I Clinical Research Unit
-
-
-
-
-
Berlin, Duitsland, 13353
- Deutsches Herzzentrum der Charité (DHZC) - Klinik für Kardiologie, Angiologie und Intensivmedizin CVK
-
-
Baden-Wurttemberg
-
Heidelberg, Baden-Wurttemberg, Duitsland, 69120
- Universitätsklinikum Heidelberg - Zentrum für Innere Medizin, Abteilung Klinische Pharmakologie und Pharmakoepidemologie
-
-
North Rhine-Westphalia
-
Bonn, North Rhine-Westphalia, Duitsland, 53127
- UK Bonn Institut für Klinische Chemie und Klinische Pharmakologie, Phase I Einheit und Arzneimitteltherapiesicherheit
-
-
Thuringia
-
Erfurt, Thuringia, Duitsland, 99084
- SocraTec R&D Erfurt-Clinical Pharmacology Unit
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Nurandociguat Arm
Participants receive nurandociguat plus 0.4 mg nitroglycerin spray |
0.4 mg sublingual spray Tablet, oral |
|
Placebo-vergelijker: Placebo Arm
Participants receive placebo matching nurandociguat plus 0.4 mg nitroglycerin spray |
0.4 mg sublingual spray Tablet matching nurandociguat, oral |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of participants with treatment-emergent adverse events per treatment group
Tijdsspanne: Up to 7 days after the last treatment, for a total of up to about 7 weeks per participant
|
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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 22597
- 2025-522335-34-00 (Ctis)
- 2025 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .