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
Diseases & Conditions
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
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 | Not Yet Recruiting | 01 Oct 2026 | 10 |
Germany | Not Yet Recruiting | 01 Oct 2026 | 26 |


