11 results
The main objective of this open-label, randomized clinical trial is to asses whether patient-controlled analgesia with remifentanil is more efficious and equally safe as pethidine as analgesic strategy during ultrasound-guided transvaginal oocyte…
To determine the influence of OATP1B inhibition, through rifampicin exposure, on the metabolism and plasma pharmacokinetics of sorafenib and its metabolites.
Primary objective:The study has hierarchical co-primary objectives to demonstrate that:- Firstly: dexmedetomidine is at least as effective as sedation with midazolam and daily sedation stops, in maintaining a target depth of sedation in ventilated…
Primary:To assess the non-inferiority of the sedative properties of continuous intravenous (i.v.) clonidine compared to continuous i.v. midazolam in mechanically ventilated children and adolescents (0 - <18 years) admitted to a paediatric…
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…
Primary objectives: To evaluate the expression of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16): - of subjects receiving apremilast compared to subjects receiving placebo;- within both groups relative to…
As of protocol Amendment 06, evaluation of the safety profile of MLN9708 and/or other study medication is the only endpoint being assessed. All other study endpoints will no longer be assessed.
Primary Objective: To evaluate the achievement of partial remission by apremilast combined with doxycyclineat week sixteen (t=16). Secondary Objectives: • Complete remission at week sixteen; • Disease control at week six (t=6); • Drug survival;•…
Study ObjectivesPrimary:• To determine the effect of ixazomib maintenance therapy on progression-free survival (PFS), compared to placebo, in patients with NDMM who have had a response (complete response [CR], very good partial response [VGPR], or…
To determine whether the addition of oral ixazomib to the background therapy of lenalidomide and dexamethasone improves progression-freesurvival (PFS) in patients with relapsed and/or refractory multiple myeloma (RRMM) The objective has been met.…
Primary ObjectiveThe primary objective of the study is to evaluate the clinical efficacy of apremilastcompared with placebo in children and adolescents (ages 6 through 17 years) withmoderate to severe plaque psoriasis.Secondary Objectives- * To…