7 results
Primary objective:To compare the change in small airways obstruction (FEF75%) in patients with CF when inhaling one ampule of inhaled tobramycin with the Akita® compared to standard of treatment (twice daily nebulization of one ampule using standard…
PrimaryObjectives: 1. Evaluate the efficacy of adding anacetrapib 100 mg for 52 weeks relative to placebo on plasma concentrations of LDL-C. 2. Evaluate the safety and tolerability of 52 weeks of treatment with anacetrapib 100 mg.Hypotheses: 1.…
- To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of radiographic progression-free survival PFS) in patients with PTEN-deficient mHSPC.
Primary objective: To determine the safety of once daily inhalation of the recommended daily dose of tobramycin with the Akita® and the PARI-LC® Plus nebulizer in patients with CF. Systemic absorption can be used as surrogate parameter for safety.…
Primary objective: To investigate whether pharmacokinetics of the recommended dose of inhaled tobramycin, defined as serum tobramycin Area Under the Curve (AUC0-24hr), with the I-neb (75 mg) is equivalent to the PariLCPlus (300 mg) nebuliser in…
The study will compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) by assessment of Overall Survival in HPV-unrelated participants. The formal statistical analysis will be performed to test the following…
The primary objectives of this trial are:• Part 1 (dose escalation): To evaluate the safety of BYON4228 alone and in combinationwith rituximab to determine the maximum tolerated dose (MTD), or optimal biological dose(OBD) if the MTD is not reached,…