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Azilsartan Medoxomil

Clinical trials investigating Azilsartan Medoxomil are studying patients with heart failure and other kidney-related conditions where an ARB is part of treatment. The trials focus on outcomes such as symptom-related markers, kidney measures, safety, and dose response. This article summarizes the trial designs, target groups, phases, and endpoints.

Table of contents

Trial overview

The trial data include two interventional studies that mention Azilsartan Medoxomil as part of the treatment background or study context.[1][2] One study is in heart failure and is completed, while the other is in focal segmental glomerulosclerosis and is authorised.[1][2]

Heart failure study

The heart failure trial is a proof-of-concept and dose-finding study of XXB750 in patients with heart failure.[1] It is a Phase 2 interventional study with 740 planned participants and a completed status.[1]

This study compares three target dose levels of XXB750 with placebo and looks at whether treatment lowers NT-proBNP, a blood marker linked to heart strain.[1] The main endpoint is the change in log NT-proBNP from baseline to Week 16.[1]

The study population includes symptomatic heart failure patients with LVEF below 50%.[1] LVEF means left ventricular ejection fraction, which is a measure of how much blood the heart pumps out with each beat.[1] Patients were treated with standard care, including ACEI/ARB or sacubitril/valsartan.[1]

Kidney disease study

The second trial is titled as a study of DMX-200 in patients with focal segmental glomerulosclerosis, which is a kidney disease that affects the filtering units of the kidneys.[2] It is a Phase 3 interventional study with 308 planned participants and an authorised status.[2]

The brief summary says the study evaluates efficacy in adult patients with FSGS who are receiving an ARB.[2] ARB means angiotensin receptor blocker, a type of background treatment mentioned in the trial record.[2]

The primary outcomes include percent change in urine PCR after treatment compared with placebo, slope of eGFR after treatment compared with placebo, and for the open-label extension, the incidence and severity of treatment-related adverse events and other important safety events.[2] Open-label means everyone in that part of the study knows which treatment is being given.[2]

Outcomes measured in the trials

In the heart failure study, the main outcome is a change in log NT-proBNP from baseline to Week 16.[1] This tells researchers whether the treatment changes a marker of heart stress over time.[1]

In the kidney study, the main outcomes are urine PCR and eGFR slope.[2] Urine PCR is a urine test used in kidney disease research, and eGFR slope shows how kidney function changes over time.[2]

The kidney study also tracks safety outcomes, including treatment-related adverse events, adverse events of special interest, and serious adverse events during long-term treatment.[2]

Who the trials include

The heart failure study includes symptomatic patients with heart failure and LVEF below 50%.[1] These patients were already receiving standard care, which helps researchers study the added effect of the trial treatment.[1]

The kidney study includes adult patients with focal segmental glomerulosclerosis who are receiving an ARB.[2] The record does not give more detailed eligibility rules in the provided data.[2]

What the trial phases mean

Phase 2 studies usually look for early signs that a treatment may work and help find a useful dose.[1] That is why the heart failure study is described as a proof-of-concept and dose-finding trial.[1]

Phase 3 studies are larger and are designed to test treatment effects and safety in more patients.[2] The kidney trial fits this pattern because it measures both benefit and safety outcomes in adults with FSGS.[2]

Trial ID Phase Condition studied Status Enrollment
2023-504678-39-00 Phase 2 Heart Failure Completed 740
NCT05183646 Phase 3 Focal segmental glomerulosclerosis Authorised 308

FAQ

  • What are clinical trials of Azilsartan Medoxomil studying? The trial data show Azilsartan Medoxomil used as one of several study treatments in a heart failure study. The main focus is on measuring treatment effects and comparing outcomes in patients already receiving standard care.
  • Who may be included in these trials? One trial includes symptomatic patients with heart failure and left ventricular ejection fraction below 50%. Another trial studies adults with focal segmental glomerulosclerosis who are receiving an ARB.
  • What phases are represented in the trial data? The heart failure study is Phase 2. The focal segmental glomerulosclerosis study is Phase 3.
  • What results are the trials measuring? The heart failure trial measures change in log NT-proBNP from baseline to Week 16. The kidney trial measures percent change in urine PCR, slope of eGFR, and safety outcomes such as treatment-related adverse events.
  • What does ARB mean in these trial records? ARB means angiotensin receptor blocker, which is a type of background treatment mentioned in the trial records. The studies include patients already receiving an ARB or other standard treatment.

Igangværende kliniske forsøg for Azilsartan Medoxomil

  • Test af lægemidlet XXB750 til behandling af hjertesvigt: Undersøgelse af virkning og bedste dosis

    Rekrutterer ikke

    1 1
    Undersøgte lægemidler:
    Bulgarien Tjekkiet Danmark Frankrig Tyskland Ungarn +5

  • Test af lægemidlet DMX-200 til behandling af nyresygdommen fokal segmental glomerulosklerose (FSGS)

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Tjekkiet Danmark Frankrig Tyskland Italien Portugal +1

Ordliste

  • Heart failure: A condition where the heart does not pump blood as well as it should. In the trial, patients had symptoms and reduced heart pumping function.
  • Focal segmental glomerulosclerosis: A kidney disease that can damage the filtering units of the kidneys. The trial studies adults with this condition.
  • Phase 2: A research stage that looks at early signs of benefit and helps find the right dose.
  • Phase 3: A larger research stage that compares treatment effects and safety in more patients.
  • Interventional study: A study where researchers give a treatment and then measure the results.
  • Placebo: A look-alike treatment with no active study drug. It helps show whether the study treatment works better than no active treatment.
  • NT-proBNP: A blood marker linked to heart strain. In the heart failure trial, the change in this marker was a main outcome.
  • Urine PCR: A urine test used in kidney disease studies. It helps measure protein in the urine.
  • eGFR: Estimated glomerular filtration rate, a measure of how well the kidneys filter blood.
  • Adverse event: A medical problem that happens during a study. It may or may not be caused by the treatment.

Referencer

  1. https://clinicaltrials.gov/study/2023-504678-39-00
  2. https://kliniske-forsoeg.dk/forsog/test-af-laegemidlet-dmx-200-til-behandling-af-nyresygdommen-fokal-segmental-glomerulosklerose-fsgs/