Suwa

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating the safety and clinical effects of Awiqli Insulin Icodec in people with diabetes mellitus in Japan through a non-interventional observational study. The study focuses on real-world use of Awiqli prescribed by doctors as part of routine clinical care, with no restrictions on diabetes type or prior treatments. This research aims to gather information about adverse reactions and clinical outcomes over a one-year period. Participants will receive commercially available Awiqli once weekly, with treatment decisions made by their doctors following normal clinical practice. The study does not assign treatment but observes patients using Awiqli as prescribed. Data will be collected throughout the 52-week period to monitor safety and clinical parameters under real-world conditions. During the study, participants will be monitored for adverse reactions, serious adverse events, and changes in blood sugar control, including glycosylated hemoglobin HbA1c and fasting plasma glucose. Quality of life related to diabetes therapy will also be assessed. The study involves regular data collection over approximately one year, and participants continue with their usual care while contributing information to the study.

Researchers are conducting a survey to study patients who have received Ondexxya Intravenous Injection 200 mg to neutralize the anticoagulant effects of Factor Xa inhibitors during life-threatening or unarrestable bleeding episodes. This observational study aims to monitor safety specifications such as thrombotic events, infusion reactions, and re-bleeding, while also understanding the drugs safety and effectiveness under real-world use. The survey collects information about the occurrence of unknown adverse drug reactions, the incidence of adverse reactions during routine use, and factors that might influence the drugs safety or effectiveness. There are no specific treatments or interventions administered as part of the study since it observes patients receiving routine care with Ondexxya. Participants will be monitored for 30 days to document adverse drug reactions and safety-related events, including how patient background factors may affect outcomes. Data collection involves safety and effectiveness information gathered during this period, with no additional procedures or visits beyond standard clinical care. The study is sponsored by AstraZeneca and will continue until October 2026.

Researchers are evaluating the long-term safety and tolerability of cenobamate in Japanese patients with partial onset seizures. This Phase 2, multicenter open-label extension study aims to monitor how well patients tolerate cenobamate over an average period of four years. The study is sponsored by Ono Pharmaceutical Co., Ltd. and focuses on patients who have completed a prior related study. Participants receive cenobamate orally once daily throughout the study. The trial does not include a comparison group or placebo, as all participants receive the investigational drug. This extension study follows patients who completed an earlier core study and continues to assess their response to long-term treatment. During the study, participants will undergo regular assessments including blood and urine tests, liver function and hematology panels, vital signs like heart rate and blood pressure, electrocardiograms, and evaluations for potential suicidal thoughts using the Columbia-Suicide Severity Rating Scale. The study aims to track any adverse events and changes in seizure frequency over the four-year period, ensuring close safety monitoring and thorough data collection.

Researchers are observing adults with severe emphysema and lung hyperinflation who are considered suitable for bronchoscopic lung volume reduction BLVR using the Zephyr Endobronchial Valve. This multicenter, prospective surveillance study involves 140 patients across up to 20 centers in Japan. The study aims to monitor safety and effectiveness over 12 months, focusing on lung function, exercise ability, breathing difficulties, and quality of life. Participants confirmed to have little or no collateral ventilation in the target lung lobe will undergo a bronchoscopy with Chartis assessment, followed by placement of the Zephyr Valve in the most affected lobe. Patients will be hospitalized for at least three nights for observation after the procedure. Those with collateral ventilation will not receive treatment and will exit the study. Participants will complete a pulmonary rehabilitation program between 45 days and 3 months after the procedure. Throughout the 12-month follow-up, lung function tests measuring forced expiratory volume in 1 second, residual volume, and a 6-minute walk test will be conducted at 3, 6, and 12 months. High-resolution CT scans will assess lung volume reduction at 45 days and 12 months. Safety is assessed by tracking treatment-related adverse events, especially the incidence of pneumothorax within 45 days after valve placement.