assignment
Not Yet Recruiting

Safety and Pharmacokinetic Evaluation of Nurandociguat in Combination with Nitroglycerin in Patients with Coronary Artery Disease

Trial ID
2025-522335-34-00
Protocol
22597
Sponsor
Bayer AG

Trial statistics

location_city
5
research sites
public
2
countries
medical_information
2
diseases
person_search
5
investigators

Objectives

The primary objective is to evaluate the safety of nitroglycerin when co-administered with nurandociguat in patients diagnosed with coronary artery disease. This assessment is clinically significant for determining potential drug-drug interactions and adverse event profiles during combination therapy. No secondary objectives were identified.

Participants

The sponsor did not provide information regarding the total number of participants. The study population consists of patients within the age ranges corresponding to codes 3 and 4. Both male and female individuals are included in the study. Participants are characterized by the presence of chronic kidney disease and coronary artery disease.

Plans and Procedures

This Phase 3 clinical trial utilizes a design to evaluate the safety and physiological effects of nitroglycerin when co-administered with nurandociguat in individuals diagnosed with coronary artery disease. The research methodology involves a sequence of study visits, beginning with a screening visit to determine eligibility. Subsequent follow-up visits are scheduled to monitor clinical outcomes, concluding with an end-of-study visit. The total duration of study activities is estimated to occur between March 2026 and October 2026. Participation may be subject to early termination based on specific clinical conditions or predefined protocol criteria.

Treatment

Please provide the source data containing the names of the medications, dosages, forms, and administration details. Once the data is provided, the description will be generated according to the specified technical and structural requirements.

Efficacy

The assessment of efficacy in this Phase 3 clinical trial involves the evaluation of outcomes related to chronic kidney disease and coronary artery disease. The specific parameters, methods for measurement, and collection schedules for efficacy endpoints are not defined in the provided documentation.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
Bulgaria BulgariaNot Yet Recruiting01 Oct 202610
Germany GermanyNot Yet Recruiting01 Oct 202626

Sites & Investigators

Conditions Studied in This Trial