Safety Evaluation of Nurandociguat in Combination with Sildenafil in Male Patients with Arterial Hypertension and Chronic Kidney Disease

The primary objective is to evaluate the safety of nurandociguat when co-administered with sildenafil in male subjects diagnosed with arterial hypertension. This assessment is clinically relevant to determine the risk profile of potential drug-drug interactions within this specific patient population.

The sponsor did not provide information regarding the total number of participants. The study population consists of male patients within the age range of 19 to 45 years. Participants are characterized by the presence of chronic kidney disease and arterial hypertension.

This Phase 3 clinical trial is designed to evaluate the safety of nurandociguat when co-administered with sildenafil in individuals diagnosed with arterial hypertension. The study utilizes a controlled methodology to assess pharmacological interactions and safety profiles. The research process commences with a screening visit to determine eligibility based on predefined criteria. Following screening, participants proceed through scheduled follow-up visits to monitor clinical parameters and safety endpoints. The sequence concludes with an end-of-study visit. The total duration of participant involvement is determined by the protocol requirements, though participation may be discontinued prematurely if specific safety or clinical conditions are met.

Efficacy assessment in this Phase 3 clinical trial focuses on the management of chronic kidney disease and arterial hypertension. Specific parameters and measurement methodologies for evaluating these conditions are not provided.