7 results
The objective of the trial is to assess the efficacy and safety of nintedanib in the treatment ofSSc with ILD at a dose of 150 mg bid compared to placebo.
Primary Safety Objective * Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602*2403 mg/d and nintedanib at a dose of 200*300 mg/d Secondary Safety Objective * Proportion of patients who discontinue…
The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…
Primary: Long-term safety and tolerability.Secondary: Long-term efficacy.
The objective of the study (phase 2) is to evaluate the effectiveness of AMG 102 in combination with Mitoxantrone and Prednisone in previously treated subjects with castrate resistant prostate cancer.
Primary: To evaluate the efficacy of retigabine as adjunctive therapy to each of the following specified monotherapy AED treatments: carbamazepine/ oxcarbazepine, lamotrigine, levetiracetam or valproic acid in subjects with partial-onset seizures (…
The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing ILD. Additional efficacy and safety endpoints will be collected to explore potential long-term effects.Please see…