6 results
The primary objective of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with PAH. This will be assessed by time…
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 objectiveTo compare the effect on pulmonary vascular resistance (PVR) of an initial triple oral regimen (macitentan, tadalafil, selexipag) versus an initial dual oral regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-…
Primary objective is the delta change in whole body insulin sensitivity upon Na-PB vs. placebo treatment. Secondary objectives are muscle mitochondrial oxidative capacity, muscle and liver fat content and energy metabolism.
Primary Objectives:* For the European Union (EU) regulatory assessment, the primary objective of Period 1 is to evaluate theefficacy of tadalafil compared with placebo, as measured by time to clinical worsening (CW) in pediatricPAH patients through…