Uberlandia

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 and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Psoriatic arthritis PsA is a long-lasting inflammatory condition affecting joints and skin in people with psoriasis. This trial evaluates how well the drug zasocitinib TAK-279 works in adults with active PsA, focusing on participants past experiences with certain treatments. The study is a phase 3 clinical trial designed to assess treatment effectiveness and safety. Participants will be randomly assigned to one of three groups one receiving zasocitinib Dose A tablets once daily for up to 52 weeks, another receiving zasocitinib Dose B tablets once daily for up to 52 weeks, and a third group receiving a placebo once daily for 16 weeks followed by either Dose A or Dose B of zasocitinib once daily through week 52. This design allows comparison of doses and placebo effects during the early treatment period. During the study, participants will undergo regular assessments including joint counts and skin evaluations to monitor disease activity and response to treatment. Researchers will measure the percentage of participants achieving specific response criteria such as the American College of Rheumatology 20 ACR20 response at week 16. Safety and other health outcomes like fatigue, physical function, and quality of life will also be tracked. Total participation can last up to 60 weeks, including treatment and follow-up periods.

Researchers are studying finerenone, a drug under development, to treat newborns, children, and young adults with heart failure caused by left ventricular systolic dysfunction LVSD. LVSD weakens the left side of the heart, making it hard to pump blood properly, which can cause symptoms such as shortness of breath, tiredness, and poor growth. This Phase 3 study aims to evaluate the long-term safety and effects of finerenone when added to standard heart failure treatment in this young population, including those rolling over from a previous study and newly enrolled newborns under 6 months old. Participants will receive finerenone treatment for up to 9 months, alongside their usual heart failure care. The study will follow them for around 10 to 11 months, depending on their enrollment status. During this time, they will attend at least six visits where the study team will monitor vital signs, take blood samples, perform physical exams, and use heart imaging tests like electrocardiograms and echocardiography. Parents or guardians will also provide feedback on medication use and, for newborns and infants, on the drugs formulation acceptability. Throughout the study, researchers will track any medical problems that arise, changes in blood potassium levels, blood pressure, and kidney function. They will also measure heart function and levels of NT-proBNP, a marker related to heart failure. After finishing treatment, participants will have a follow-up health check one month later. This careful monitoring helps the team understand the safety and effects of finerenone in children and young adults with heart failure and LVSD.

Researchers are investigating a new treatment for children with heart failure and left ventricular systolic dysfunction LVSD, a condition where the heart cannot pump enough blood. This study aims to find out if finerenone, a drug that blocks a protein involved in heart and blood vessel damage, can help improve heart function compared to a placebo. This is the first study to test finerenone specifically in children with these heart problems. Participants aged 6 months to less than 18 years with heart failure and LVSD will be randomly assigned to receive either finerenone or a placebo for about 3 months, while continuing their usual heart failure care. After this period, those who qualify can join a 9-month open-label extension where everyone receives finerenone. Participants not joining the extension will have a follow-up visit 30 days after their last treatment. During the study, children will visit the study site at least three times for physical exams, heart tests like ECG and echocardiogram, blood pressure and vital sign checks, blood samples, and medication and side effect reviews. Researchers will measure changes in NT-proBNP, a protein indicating heart stress, and monitor safety through tracking adverse events and other heart and kidney function tests. The total participation can last up to approximately one year including the extension phase.

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.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

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 two different chemotherapy regimens following long-course chemoradiation therapy for patients with distal rectal cancer. The study aims to compare fluoropyrimidine alone versus fluoropyrimidine combined with oxaliplatin in consolidation chemotherapy to determine their effect on tumor response and the potential for organ preservation through a Watch and Wait strategy. This multi-center trial focuses on patients with MRI-defined distal rectal tumors classified as mrT2-3N0-1 and assesses tumor response after 12 weeks from radiotherapy completion. Participants receive 54 Gy of radiotherapy with daily capecitabine during treatment, followed by consolidation chemotherapy starting one week after radiotherapy ends. One group receives fluoropyrimidine alone, while the other receives fluoropyrimidine plus oxaliplatin, with dosing schedules of either mFOLFOX6 or CAPOX over approximately 12 weeks. Tumor response is centrally reviewed at 12 and 18 weeks, with decisions about continuing organ preservation or proceeding to surgery made by a central committee blinded to treatment assignment. Throughout the study, participants undergo clinical exams, endoscopic assessments, and high-resolution MRI to monitor tumor changes and response. The primary outcome is the decision to proceed with the Watch and Wait approach based on clinical complete response at 18 weeks post-radiotherapy. Secondary outcomes include surgery-free survival, total mesorectal excision-free survival, distant metastases-free survival, local regrowth-free survival, and colostomy-free survival assessed over three years. The study includes ongoing safety monitoring and follow-up to evaluate long-term outcomes.