2 results
Approved WMOCompleted
Primary: The primary objective of this study is to evaluate the long-term safety of SPD489 administered as adaily morning dose (30, 50, and 70mg) in the treatment of children and adolescents (6-17 years of ageinclusive at the time of consent in this…
Approved WMOCompleted
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…