6 results
The primary objective of the trial is to demonstrate non-inferiority of treatment with TMC278 when administered as 75 mg q.d. compared to the control group (EFV) in regard to the proportion of virologic responders (plasma viral load < 50 HIV-…
- To evaluate the effect of steady-state TMC278 25 mg q.d. on the steady-state pharmacokinetics of R- and S-methadone.- To evaluate the potential effect of TMC278 on the pharmacodynamic effects of methadone therapy; - To evaluate the steady state…
This study involves research and the objective of this study is to evaluate how much and how fast TMC278 is absorbed into the body after administration as these concept pediatric formulations compared to when administered as the 25 mg TMC278 tablet…
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Efficacy and quality of life.
The purpose of this study is to seek regulatory approval for use of fingolimod in a pediatric population with MS aged 10 to less than 18 years old. This study is conducted in line with the Pediatric Investigational Plan agreed with the EMA (under EU…
Primary Objective: to show a reduction in eGFR decline in patients treated with LCP tacrolimus compared to IR tacrolimus. Secondary objectives will include investigating the potential decline in other known side effects of calcineurin inhibitors i.e…