14 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 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 (…
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: *…
1) To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoproteincholesterol (LDL-C) after 24 weeks of treatment in patients with diabetes treated with insulin and with…
To explore the inflammatory changes of a PCSK-9 inhibitor compared with placebo on postprandial lipemia and postprandial leukocyte activation, oxidative stress and endothelial function in men with type 2 diabetes mellitus.
The primary objective of the study is to evaluate neurocognitive function with use of Praluent after 96 weeks of treatment versus placebo.
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 assess PK of MPhs and MP.
Primary objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) patients age of 8 to 17 years, with LDL-C *130 mg/dL (3.37…
Primary objective- To evaluate the effect of LDL-C lowering by means of the PCSK9 inhibitor alirocumab as compared with placebo on the change in percent atheroma volume (PAV) in non-infarct-related coronary arteries of patients who present with…
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…
Primary objective: To evaluate the efficacy of alirocumab, on low-density lipoprotein cholesterol (LDL-C) levels of treatment in children with homozygous familialhypercholesterolemia (hoFH) 8 to 17 years of age on top of background treatments.…
Primary goal: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in children with heterozygous familial…