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 Objective:To describe the total apparent CYP3A mediated clearance (Cl/F) of midazolam in the paediatric intensive care population from the age of 0 to 6 years, as surrogate marker of intestinal and hepatic CYP3A activity.Secondary Objectives…