In short
Clinical trials investigating Azilsartan Medoxomil are studying how it is used in research settings for different patient groups. The trial data here includes studies in heart failure and focal segmental glomerulosclerosis, with goals such as measuring efficacy, safety, and dose response. These studies involve adults receiving standard treatment or an ARB.
Key points
- Clinical trials involving Azilsartan Medoxomil in the provided data are focused on heart failure and focal segmental glomerulosclerosis. One study is a Phase 2 heart failure trial with 740 participants, looking at change in NT-proBNP over 16 weeks. The other is a Phase 3 kidney disease trial with 308 adults, measuring urine protein and kidney function over time. The trials include patients receiving standard treatment or an ARB. The main goals are to understand treatment effect, dose response, and safety in these patient groups.
Trial overview
The trial data provided includes two interventional studies that mention Azilsartan Medoxomil in the research setting. One study is in people with heart failure, and the other is in adults with focal segmental glomerulosclerosis, which is a kidney disease.
These studies are not simple drug description pages; they are designed to test clinical questions such as how well treatment works, how different doses compare, and what safety results look like in the study groups.
Heart failure study
The heart failure trial is a Phase 2 proof-of-concept and dose-finding study with 740 participants. It is a completed interventional study in symptomatic patients with heart failure and LVEF below 50%, meaning the heart pumps less than normal.
This study compares three target dose levels of XXB750 with placebo and looks at dose response, which means whether higher or lower doses lead to different results. The study population was also on standard care, including ACEI/ARB or sacubitril/valsartan, so the trial reflects treatment on top of usual heart failure care.
NT-proBNP is the main marker used in this trial, and the primary outcome is the change in log NT-proBNP from baseline to Week 16. In simple terms, the researchers are checking whether the study treatment lowers a blood marker linked to heart strain over time.
Kidney disease study
The second trial is a Phase 3 study in adults with focal segmental glomerulosclerosis and has 308 participants. Its status is authorised, and it is an interventional study.
This study evaluates the efficacy and safety of DMX-200 in patients who are already receiving an ARB. The source data does not say that Azilsartan Medoxomil is the main treatment in this trial, but it appears in the overall trial data provided for this article.
The main outcomes are the percent change in urine PCR, which measures protein in the urine, and the slope of eGFR, which shows how kidney function changes over time. The study also includes an open-label long-term part to check the incidence and severity of treatment-related adverse events, adverse events of special interest, and serious adverse events.
Key endpoints and what they mean
An endpoint is a main result researchers measure to see whether a trial is working. In the heart failure study, the endpoint is the change in log NT-proBNP from baseline to Week 16. In the kidney study, the endpoints are urine PCR and eGFR slope, plus long-term safety measures in the open-label period.
- Change in log NT-proBNP means the trial checks whether this heart failure blood marker goes down after treatment.
- Urine PCR measures how much protein is lost in urine, which helps show kidney damage.
- eGFR slope shows whether kidney function is getting better, staying stable, or getting worse over time.
- Adverse events are unwanted medical problems that happen during a study, and serious adverse events are the more severe ones.
Who can participate
The heart failure study includes symptomatic patients with LVEF less than 50% who are being treated with standard heart failure medicines. This means the study is aimed at people whose heart function is reduced and who still have symptoms.
The kidney study includes adult patients with focal segmental glomerulosclerosis who are receiving an ARB. The source data does not give more detailed rules such as age limits beyond adults, but it does show that ongoing ARB treatment is part of the study population.
Study phases and status
The heart failure study is Phase 2 and is marked as completed. Phase 2 studies often help researchers understand early effectiveness and the best dose range.
The kidney study is Phase 3 and is marked as authorised. Phase 3 studies are usually larger and are used to confirm treatment effects and collect more safety information.
Across the provided trial data, the main theme is research in chronic diseases where treatment response can be measured with lab markers and kidney or heart function measures.