Markkleeberg

Researchers are studying severe eosinophilic asthma patients who are treated with benralizumab in everyday medical settings in Germany. This prospective observational study aims to understand how well asthma is controlled, how patients quality of life is affected, changes in lung function, and medication use over time. The study focuses on patients receiving high-dose inhaled corticosteroids plus long-acting beta agonists and prescribed benralizumab according to approved guidelines. Patients will be followed for up to 52 weeks while they receive their usual benralizumab treatment without any changes directed by the study. Asthma control will be assessed using standard tests like the Asthma Control Test ACT and the Asthma Impairment and Risk Questionnaire AIRQ at various times. Quality of life will be measured with the mini Asthma Quality of Life Questionnaire miniAQLQ at the start and during routine visits. Patients will also keep a weekly record of their asthma medication intake using a paper or electronic diary. During the study, participants will have regular assessments of asthma control, lung function, and medication usage. Researchers will analyze changes in scores from questionnaires, doses of inhaled corticosteroids, and lung function measures such as forced expiratory volume and capacity. Biomarkers including eosinophils, immunoglobulin E, and exhaled nitric oxide will be monitored. The study will evaluate outcomes at baseline and weeks 12, 24, and 52 to better understand real-life effects of benralizumab treatment. Participants must be willing to regularly report their symptoms and medication use throughout the study period.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus MACE-PLUS in adults with established atherosclerotic cardiovascular disease ASCVD or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are evaluating the real-world use, effectiveness, and safety of triple therapy combining bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin in adults with primary hypercholesterolemia or mixed dyslipidemia. This observational study focuses on how well this combination lowers LDL cholesterol LDL-C and its safety when used in clinical practice, addressing the limited data currently available on such combination treatments. The study observes patients who have started triple therapy with bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin without administering any drugs as part of the trial. Participants will be followed for up to one year after beginning triple therapy. The study does not compare rosuvastatin and atorvastatin directly but assesses the overall impact of the triple therapy on LDL-C levels. Participants will have their LDL-C levels measured at 8 weeks and one year after starting triple therapy to evaluate effectiveness. Researchers will also track goal attainment based on guidelines, changes in laboratory values, adherence to therapy, and any adverse events. Cardiovascular events such as non-fatal heart attacks, strokes, and deaths will be monitored during the follow-up. Treatment changes and the patient journey over the year will also be recorded. The total participation time is up to one year after therapy initiation.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are evaluating maridebart cafraglutide in adults aged 45 to 99 years who have atherosclerotic cardiovascular disease and are overweight or obese. The study aims to determine if maridebart cafraglutide, when added to standard care, is better than a placebo in reducing serious heart-related problems and deaths. This is a Phase 3 randomized, double-blind, placebo-controlled trial sponsored by Amgen. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given as subcutaneous injections. The study treatment is given alongside their usual care. The trial will last for approximately 35 months, during which time researchers will monitor cardiovascular events such as heart attacks, strokes, and deaths, as well as other health measures. During the study, participants will have regular visits for monitoring safety and health status. Researchers will assess heart-related events, blood pressure, body measurements, blood markers such as cholesterol and blood sugar levels, and kidney function. The main outcomes include time to first major cardiovascular event and changes in various health indicators over about three years. Safety monitoring will continue throughout the trial period.

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.

Researchers are evaluating how Dupilumab affects health-related quality of life, patient characteristics, efficacy, and safety in adults with Chronic Obstructive Pulmonary Disease COPD in a real-world setting over 24 months. This non-interventional study observes patients who have started Dupilumab treatment independently of the study, focusing on those with uncontrolled COPD despite standard inhaled therapies and elevated blood eosinophils. Patients receive Dupilumab as prescribed in routine clinical practice, with no treatment assigned by the study itself. The study collects data over two years, documenting changes in COPD symptoms, lung function, exacerbation rates, and safety outcomes as patients continue their usual care. During the study, participants clinical data, including COPD Assessment Test CAT scores, lung function tests, exacerbation frequency, and adverse events, are monitored at regular intervals up to 24 months. Patient-reported outcomes and other health measures are collected to understand Dupilumabs long-term effects in everyday use. The study also gathers information on hospitalizations, workdays missed, and reasons for treatment initiation.

Researchers are evaluating the effect of abelacimab compared to a placebo on reducing the rate of ischemic stroke or systemic embolism in patients with atrial fibrillation who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients, including those who may have increased bleeding risks and cannot or choose not to take standard blood thinners. Participants will be randomly assigned to receive either abelacimab 150 mg or a matching placebo through a monthly subcutaneous injection. The study is designed as a double-blind, placebo-controlled trial to monitor the safety and efficacy of abelacimab over a period of up to 30 months. During the study, participants will be closely monitored for the time to first occurrence of ischemic stroke, systemic embolism, and bleeding events classified by the Bleeding Academic Research Consortium. Researchers will also track cardiovascular and all-cause mortality, as well as other cardiovascular events. Participants will undergo regular assessments, including electrocardiograms and clinical evaluations, throughout the trial to ensure safety and collect data on treatment effects.

Researchers are evaluating the drug omecamtiv mecarbil to see if it can reduce the risks associated with heart failure in patients who have severely reduced heart pumping ability, known as ejection fraction. This phase 3 study focuses on whether the drug can lower the chances of cardiovascular death, heart failure events, the need for heart assist devices or transplantation, and stroke in symptomatic patients. The study is supported by Cytokinetics and is designed to provide important information on how this drug may affect these serious outcomes. Participants will be randomly assigned to one of two groups one group will receive omecamtiv mecarbil tablets at doses of 25, 37.5, or 50 mg twice daily based on blood levels of the drug, while the other group will receive placebo tablets twice daily. Treatment will continue until at least 850 participants have experienced a heart failure event or cardiovascular death. The study includes a plan for an interim review based on these events and is expected to last about three years. During the study, participants will be closely monitored for heart failure events, cardiovascular death, stroke, and other serious outcomes. Researchers will measure the time until the first occurrence of these events from the start of treatment. Regular assessments will evaluate safety and treatment effects. The total participation time for each person may be up to three years, with ongoing follow-up until the study ends.