5 results
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
Primary Objectives: The primary objectives of this study are to evaluate the efficacy and safety of IV sildenafil when added to iNO for the treatment of neonates with PPHN or hypoxic respiratory failure and at risk for PPHN. Secondary Objectives: *…
To investigate the feasibility of the implementation of a point-of-care immunological test based on blood cells of all trauma patients with the aid of an automated load-and-go flow cytometer in an acute trauma care setting at the shock room.
Primary objective: To demonstrate pharmacokinetic comparability of 3D-printed sildenafil tablets and the originator sildenafil tablets following a single 20 mg dose in healthy adult subjects.Secondary objectives:• To describe the plasma…
The relative effects of sildenafil on mortality when administered at the three doses indicated above in adults with PAH will be evaluated in this clinical study. In addition, the relative effects on clinical worsening and 6-minute walking distance (…