9 results
Primary objectiveTo investigate wether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output in HFpEF patients with PHSecondary objectivesTo investigate wether Sildenafil treatment results in a…
The primary efficacy variable is if the TachoSil application was feasible. A feasible application implies that the entire TachoSil adhere, TachoSil covers at least 1 cm beyond the margins of the anastomosis line and if more TachoSil sponges are used…
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 evaluate the effect of parenteral supplementation of fishoil based emulsion (rich in omega-3 fatty acids) compared with a soy bean oil emulsion (rich in omega-6 fatty acids) on the leukocyte functions (amongst others production of TNF-α and other…
The primary objective of the study is to provide evidence that the use of a sealing surgical patch applied to the surgical field following parotidectomy is non-inferior in efficacy to the common practice of CSD insertion by wound closure, measured…
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 (…
The primary objective is to assess the proportion of patients in each treatment arm with a satisfactory clinical response as defined by a composite primary endpoint at Week 24.The secondary objective is to demonstrate safety and clinical effect at…
To determine the most effective drug (iNO or IV sildenafil) for the treatment of PH in newborns with CDH and to reach evidence based dosing of this drug. Subsequently this drug will be added to the international guidelines for the treatment of…
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…