Talcahuano

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 the safety, effectiveness, and how the body processes and responds to atumelnant treatment in children with classic congenital adrenal hyperplasia CAH. This Phase 23 study includes a double-blind, randomized portion and an open-label extension to better understand treatment effects in pediatric participants aged 1 to under 18 years. The study is designed with multiple parts, including sequential cohorts based on age groups to carefully monitor safety and outcomes. Participants will receive atumelnant tablets once daily by mouth with doses adjusted based on their weight. The study is divided into three parts Part A involves open-label, semi-sequential cohorts for children aged 12 to under 18 and later for those aged 1 to 11 Part B is a randomized, double-blind, placebo-controlled phase evaluating active treatment versus placebo and Part C is an open-label extension where participants from Parts A and B may continue treatment. Safety reviews guide progression between cohorts. Throughout the study, participants will have their hormone levels monitored, including morning serum androstenedione and 17-hydroxyprogesterone, along with blood concentration measurements of atumelnant. The trial tracks changes in glucocorticoid doses and hormone levels over time up to 260 weeks in the extension phase. The study also assesses treatment compliance and overall safety, with participation lasting from initial screening through extended follow-up.

Researchers are conducting a phase 2, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohns Disease CD. The main goal is to compare different doses of SAR441566 against placebo in these participants. The study is sponsored by Sanofi and aims to understand how well SAR441566 works in treating CD. Participants will be randomly assigned to receive one of three different doses of SAR441566 or a matching placebo. The treatment is given orally as tablets. The study lasts up to 59 weeks, including a 4-week screening period, followed by a 52-week main treatment phase. This main phase has a 12-week double-blind induction period and a 40-week maintenance period. Eligible participants may also enter an open-label extension lasting up to 40 weeks, but the combined duration of the maintenance and open-label periods cannot exceed 40 weeks. Throughout the study, participants will visit regularly for assessments including endoscopy, stool frequency and abdominal pain scoring, and blood tests to measure drug levels and safety. Researchers will measure outcomes such as endoscopic response at week 12 and clinical remission using various indices. Safety will be monitored by tracking adverse events up to week 52. After treatment, a 2-week follow-up occurs for those not continuing in the long-term safety study, with total participant involvement lasting up to 59 weeks.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are conducting an international, multicenter observational study to understand acute kidney injury requiring renal replacement therapy AKI-RRT in Latin American countries. The study focuses on the epidemiology, outcomes, and care processes for patients with AKI-RRT, comparing variations across different countries and examining factors such as demographics, clinical profiles, and socioeconomic status that may influence patient outcomes. The aim is to establish a comprehensive database to support clinical research and improve understanding of AKI-RRT in this region. The study observes critically ill adult patients admitted to intensive care units ICUs who are undergoing any form of renal replacement therapy. It collects detailed clinical, laboratory, treatment, and outcome data without assigning treatments, as it is observational. Patients are followed from enrollment through hospital discharge or up to 90 days, including ICU stay and 90-day post-ICU follow-up to track mortality, renal recovery, and complications related to renal replacement therapy. Participants involvement includes monitoring during ICU and hospital stays with data collected on mortality rates, length of stay, renal function recovery, dependence on renal replacement therapy, and complications such as infections or anticoagulation issues. The primary outcome measured is in-hospital mortality, with secondary outcomes covering ICU mortality, 90-day mortality, length of stay, recovery, and procedural complications. This study spans from enrollment until 90 days after ICU admission, providing extensive observational data on AKI-RRT in Latin America.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Researchers are evaluating the safety and effectiveness of the Vienna Aortic Valve SE System, a new self-expanding transcatheter heart valve, in patients with symptomatic severe aortic stenosis. This prospective, single-arm, multicenter trial includes up to 267 patients and follows them for up to five years after valve implantation. The study aims to gather important data beyond an initial feasibility study to better understand this devices performance over time. Participants will receive the Vienna Aortic Valve SE System through a transcatheter aortic valve implantation TAVI procedure. After implantation, patients will have 11 scheduled visits, including follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years. These visits allow researchers to monitor the devices safety and effectiveness throughout the study period. During the trial, participants will undergo clinical evaluations including assessments of mortality, valve function, and heart-related events. Quality of life and exercise capacity will also be measured. Monitoring includes checking for complications like bleeding or conduction problems requiring pacemakers. The study concludes after each participant completes their 5-year follow-up visit, providing long-term information on the valve systems outcomes.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.