5 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-…
The objective of this study is to evaluate the safety, tolerability and pharmacokinetics of AIN457 and to compare the efficacy of AIN457 with placebo, in patients with active RA when administered in combination with a stable dose of methotrexate.…
The primary efficacy objectives of this two-cohort study are:o To demonstrate that ZX008 is superior to placebo as adjunctive therapy in the treatment of symptoms of Dravet syndrome in children and young adults based on change in the frequency of…
The primary objective of Part 1 is the primary objective of the entire study.Part 1The primary objective of Part 1 is:* To evaluate the effect of ZX008 0.8 mg/kg/day versus placebo as adjunctive therapy for the treatment of uncontrolled seizures in…
Objectives for Part 1: Primary (Efficacy): To demonstrate that the efficacy of fenfluramine (ZX008) 0.8 mg/kg/day is superior to placebo as an adjunctive therapy for pediatric and adult subjects with CDD Secondary (Safety): To characterize the…