Markkleeberg

Researchers are evaluating asthma control, health-related quality of life (HRQL), lung function, and asthma medication use in patients with severe eosinophilic asthma treated with benralizumab in a real-life clinical setting in Germany. This prospective, non-interventional, single-arm, multicenter study aims to observe these outcomes over a 52-week period to better understand benralizumab's impact outside of randomized clinical trials. Patients prescribed benralizumab according to label and local reimbursement criteria will be followed for up to 52 weeks. The study will monitor asthma control using the Asthma Control Test (ACT) and the Asthma Impairment and Risk Questionnaire (AIRQ®) at various timepoints. Health-related quality of life will be assessed with the mini Asthma Quality of Life Questionnaire (miniAQLQ) at baseline and routine follow-up visits. Patients will also track and report their weekly asthma medication intake using either paper-based or electronic diaries throughout the study. Participants will complete questionnaires every 4 weeks and record medication intake weekly. Researchers will measure changes in ACT scores, proportions of responders, and reductions in inhaled corticosteroid doses from baseline to weeks 12, 24, and 52. Safety and health outcomes will be observed under routine clinical care. This study includes adults aged 18 to 120 years with severe eosinophilic asthma who can understand study instructions and provide informed consent.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are evaluating the effects of baxdrostat combined 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 systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are evaluating the long-term effects of Dupilumab treatment on patients with Chronic Obstructive Pulmonary Disease (COPD) in a real-world setting over 24 months. The study focuses on changes in health-related quality of life, patient characteristics, effectiveness, and safety of Dupilumab for those whose COPD remains uncontrolled despite standard therapies and who have elevated blood eosinophils. This is a non-interventional study where patients receive Dupilumab as prescribed by their doctors according to approved guidelines, without any treatment administered by the study itself. Dupilumab treatment initiation happens independently from study recruitment, and patient data is collected during routine clinical care. Participants will be involved for up to 12 months with assessments including monitoring changes in the COPD Assessment Test (CAT) score from baseline. Data is gathered through clinical evaluations and patient-reported outcomes. Safety and effectiveness are observed through regular documentation of clinical health and patient experiences during their ongoing treatment.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.

Researchers are evaluating the effectiveness and safety of the investigational drug omecamtiv mecarbil in patients with symptomatic heart failure and severely reduced ejection fraction. This study aims to see if the drug can lower the risk of serious heart-related events, such as cardiovascular death, heart failure events, need for heart device implantation, heart transplantation, or stroke. The study is a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial involving adults aged 18 to 85 years. Participants will be randomly assigned to receive either omecamtiv mecarbil or a placebo, both given as oral tablets. The study is event-driven and will continue until at least 850 participants have experienced either a heart failure event or cardiovascular death. An interim analysis will be done after about 570 such events have occurred. The estimated participation period for each patient is up to 3 years. During the study, participants will be monitored for the time until the first occurrence of cardiovascular death or heart failure event. Researchers will collect various health data and monitor safety throughout the study. The study includes regular assessments to track heart function and adverse events, with follow-up until the study concludes when the required number of events is reached.