Odunpazari

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating whether the medicine empagliflozin helps children and adolescents aged 2 to 17 who have chronic kidney disease (CKD). This phase 3 study also aims to learn how well empagliflozin is tolerated and how the body processes it in young patients with CKD. The study includes children with CKD of various causes, focusing on kidney function and urine albumin levels. Participants are randomly assigned to one of two groups: one group takes empagliflozin tablets once daily, and the other takes placebo tablets once daily. The chance of being assigned to empagliflozin is twice as high as placebo. This treatment lasts for 6 months in a double-blind phase. After that, all participants take empagliflozin once daily for an additional year during an open-label extension. During the study, which lasts about 18 months, participants visit the study site around 15 times and have at least 5 phone or video calls with study staff. At visits, doctors collect blood and urine samples and regularly check health and any side effects. The main outcomes measured include changes in urine albumin-creatinine ratio and urine glucose levels over 24 weeks. Safety and tolerability are closely monitored throughout the study.