6 results
Primary: Effectivity. Secundary: Effectivity (questionnaires, progression, surgery), safety and tolerability.
Primary objective: Single-ascending dose (SAD) and multiple-ascending dose (MAD) phases of the study: *To establish the safety and tolerability of single- and multiple-ascending dose(s) of KHK6640, respectively, in subjects with prodromal Alzheimer*…
Primary: To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with Combodart, compared to placebo. Secondary: changes in sexual function during 1st 9 months of the study,…
Primair eindpunt:Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Homozygous or Heterozygous for the F508del Mutation.Secundair eindpunt:Evaluate the long-term efficacy of VX-…
Primary objective (Parts A and B):To evaluate the long-term safety and tolerability of VX-445/TEZ/IVA in subjects with CF who are heterozygous for the F508del mutation and a gating (F/G) or residual function (F/RF) mutation.Secondary objectives (…
Primary Objectives: To investigate the pharmacokinetic interaction of elexacaftor/tezacaftor/ivacaftor and tacrolimus in adult CF patients using tacrolimus after renal or liver transplantation by:- quantitating the effect of elexacaftor/tezacaftor/…