Table of Contents
- Trial overview
- Heart failure study
- Kidney disease study
- Key endpoints and what they mean
- Who can participate
- Study phases and status
Trial overview
The trial data provided includes two interventional studies that mention Azilsartan Medoxomil in the research setting.[1][2] One study is in people with heart failure, and the other is in adults with focal segmental glomerulosclerosis, which is a kidney disease.[1][2]
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.[1][2]
Heart failure study
The heart failure trial is a Phase 2 proof-of-concept and dose-finding study with 740 participants.[1] It is a completed interventional study in symptomatic patients with heart failure and LVEF below 50%, meaning the heart pumps less than normal.[1]
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.[1] 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.[1]
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.[1] In simple terms, the researchers are checking whether the study treatment lowers a blood marker linked to heart strain over time.[1]
Kidney disease study
The second trial is a Phase 3 study in adults with focal segmental glomerulosclerosis and has 308 participants.[2] Its status is authorised, and it is an interventional study.[2]
This study evaluates the efficacy and safety of DMX-200 in patients who are already receiving an ARB.[2] 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.[2]
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.[2] 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.[2]
Key endpoints and what they mean
An endpoint is a main result researchers measure to see whether a trial is working.[1][2] In the heart failure study, the endpoint is the change in log NT-proBNP from baseline to Week 16.[1] In the kidney study, the endpoints are urine PCR and eGFR slope, plus long-term safety measures in the open-label period.[2]
Change in log NT-proBNP means the trial checks whether this heart failure blood marker goes down after treatment.[1]
Urine PCR measures how much protein is lost in urine, which helps show kidney damage.[2]
eGFR slope shows whether kidney function is getting better, staying stable, or getting worse over time.[2]
Adverse events are unwanted medical problems that happen during a study, and serious adverse events are the more severe ones.[2]
Who can participate
The heart failure study includes symptomatic patients with LVEF less than 50% who are being treated with standard heart failure medicines.[1] This means the study is aimed at people whose heart function is reduced and who still have symptoms.[1]
The kidney study includes adult patients with focal segmental glomerulosclerosis who are receiving an ARB.[2] 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.[2]
Study phases and status
The heart failure study is Phase 2 and is marked as completed.[1] Phase 2 studies often help researchers understand early effectiveness and the best dose range.[1]
The kidney study is Phase 3 and is marked as authorised.[2] Phase 3 studies are usually larger and are used to confirm treatment effects and collect more safety information.[2]
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.[1][2]
