13 results
1) To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoproteincholesterol (LDL-C) after 24 weeks of treatment in patients with diabetes treated with insulin and with…
To explore the inflammatory changes of a PCSK-9 inhibitor compared with placebo on postprandial lipemia and postprandial leukocyte activation, oxidative stress and endothelial function in men with type 2 diabetes mellitus.
The primary objective of the study is to evaluate neurocognitive function with use of Praluent after 96 weeks of treatment versus placebo.
Primary objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) patients age of 8 to 17 years, with LDL-C *130 mg/dL (3.37…
Primary objective- To evaluate the effect of LDL-C lowering by means of the PCSK9 inhibitor alirocumab as compared with placebo on the change in percent atheroma volume (PAV) in non-infarct-related coronary arteries of patients who present with…
To assess the efficacy of SARS-CoV-2 vaccination by the incidence of COVID-19 in patients with chronic kidney disease stage G4-G5, on dialysis and patients after kidney transplantation who received SARS-CoV-2 vaccination
To investigate, in RA patients, the role of different RTX doses (200, 500 and 1000mg) and timing of RTX on risk of obtaining adequate humeral response against COVID-19 vaccines, by performing a sensitivity analysis on response, using logistic…
The primary objective of this study is to demonstrate clinical benefits of consumption of plant stanols (delivered via products enriched with plant stanol esters) on the vaccination response to a COVID-19 vaccine in overweight or obese patients aged…
To explore the change in circulating biomarkers of activation of the coagulation system before and after SARS-CoV2 vaccination (AstraZeneca).
Primary objective: To evaluate the efficacy of alirocumab, on low-density lipoprotein cholesterol (LDL-C) levels of treatment in children with homozygous familialhypercholesterolemia (hoFH) 8 to 17 years of age on top of background treatments.…
Primary goal: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in children with heterozygous familial…
Phase IPrimary Objective- To define the recommended phase II dose (RP2D) of selumetinib/dexamethasone combination in adult and paediatric patients with relapsed/refractory, RAS pathway mutant ALLSecondary Objectives- To evaluate safety and…
Primary objectives:- To determine the PK of selumetinib after administration of the selumetinib granule formulation. - To assess the safety and tolerability of the selumetinib granule formulation.