Thanh Pho Rach Gia

Researchers are studying the effects of combining baxdrostat with dapagliflozin in adults who have chronic kidney disease (CKD) and high blood pressure (hypertension). This Phase III, international, multicenter, double-blind, placebo-controlled trial aims to evaluate whether this combination can reduce the risk of significant kidney function decline, kidney failure, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes a 4-week period where participants not already on SGLT2 inhibitors take dapagliflozin alone. Afterward, participants are randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those in the baxdrostat group may start on a lower dose and increase if needed. Treatment continues with regular visits scheduled at 2, 4, 8, 16, 34, and 52 weeks after randomization, followed by visits approximately every 4 months. If study medication is stopped early, participants continue dapagliflozin if possible and remain in the study for ongoing monitoring. During the trial, participants will have various assessments including kidney function tests, blood pressure measurements, and monitoring for heart and kidney events. The main outcome is to see if the combination reduces the risk of major kidney and heart problems over up to 37 months. Safety and tolerability will also be closely followed. The study will end once a set number of key health events have occurred, with a final visit planned for all participants to collect last data and ensure ongoing care.

Researchers are evaluating the safety, immune response, and effectiveness of the V181 dengue vaccine in healthy children aged 2 to 17 years. This study aims to show that V181 can reduce the number of confirmed dengue cases caused by any of the four dengue virus types, regardless of whether participants had prior dengue exposure. The trial is a Phase 3, randomized, double-blind, placebo-controlled study sponsored by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive a single 0.5 mL subcutaneous dose of either the V181 vaccine or a placebo on Day 1. About 3600 participants will be monitored for immune response and safety for 28 days after vaccination in the Reactogenicity and Immunogenicity Subset. A smaller group of approximately 620 participants will be followed up to 5 years to evaluate long-term immune responses using virus neutralization tests. During the study, participants will be regularly assessed for adverse events, including injection site reactions and systemic symptoms, up to 28 days after vaccination and for serious adverse events up to 5 years. The study will track occurrences of dengue infections requiring medical attention and hospitalizations over approximately 3 to 5 years. Researchers will also measure antibody levels and immune responses at multiple time points. Participation involves follow-up visits and monitoring for up to 5 years after vaccination.

Researchers are evaluating the efficacy and safety of two different doses of AZD6793 tablets compared to placebo in adults with moderate to very severe chronic obstructive pulmonary disease (COPD). This Phase IIb randomized, double-blind, placebo-controlled study aims to better understand how AZD6793 affects COPD exacerbations and lung function. Approximately 970 participants will be enrolled across about 350 sites worldwide. Participants will be randomly assigned to one of three groups: one group will receive Dose 1 of AZD6793, another will receive Dose 2, and the third group will receive matching placebo tablets. The study duration is 24 weeks, during which the treatments will be administered orally. The study design includes parallel groups and quadruple blinding to ensure unbiased results. Throughout the 24-week study, participants will undergo regular assessments such as lung function tests measuring forced expiratory volume (FEV1), symptom scales like the Breathlessness, Cough and Sputum Scale (BCSS), COPD Assessment Test (CAT), and St George's Respiratory Questionnaire (SGRQ). Researchers will monitor the rate and timing of moderate or severe COPD exacerbations, collect blood samples to measure AZD6793 levels, and assess safety. This comprehensive monitoring will help evaluate the study drug's impact and participants' health during the trial.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with elevated systolic blood pressure, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial designed to assess heart failure events and cardiovascular death risks. Participants will be randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Those in the baxdrostat group may have their dose increased if they meet specific criteria. Before randomization, participants not already on SGLT2 inhibitors or treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg daily for 4 to 6 weeks. Study visits are scheduled at 2, 4, 8, 16, and 34 weeks after randomization, then approximately every four months. If a participant stops the blinded study treatment early, they will continue with open-label dapagliflozin unless specific discontinuation criteria are met. During the study, participants will undergo screening assessments, follow-up visits for monitoring, and data collection up to the study closure point based on event rates, which may last up to 38 months. Researchers will measure the occurrence of heart failure events, cardiovascular death, hospitalizations, and other cardiovascular outcomes. Participants will continue with scheduled visits and assessments even if they discontinue the blinded treatment, ensuring ongoing data collection and safety monitoring throughout the study period.