6 results
To assess long term safety and toleralibility of Pitavastatin 4 mg QD. To assess the efficacy of Pitavastatin (4 mg) and simvastatin (40 mg and 80 mg QD) in terms of LDL-C target attainment (EAS and NCEP) following 16 weeks and 44 weeks of treatment…
Primary Objective * To evaluate the effect of a 6-week treatment with elafibranor versus placebo on hepatic lipid composition in subjects with a fatty liver.Secondary objectives * To evaluate the between treatment difference (elafibranor 120 mg/d vs…
Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of selinexor added to standard induction chemotherapy for AMLand select the feasible dose level for part B of the study2. To assess in a randomized…
Part I: Evaluate the safety and tolerability of selinexor at 3 different dose levels in combination with bortezomib/dexamethasone & determine recommended dose level (RDL) of selinexor for Part IIPart II: Evaluate the efficacy of the…
Primary objectives * surrogate endpoint (at interim analysis)To evaluate the efficacy of elafibranor QD for 72 weeks versus placebo on resolution of NASH without worsening of fibrosis.* Resolution of NASH is defined as the disappearance of…
The primary objective of the study is to compare the PFS of SPd versus EloPd in patients with MM who have received 1 to 4 prior anti-MM lines of therapy and never received pomalidomide, selinexor, or elotuzumab. Patients must have had prior…