Table of Contents
- Trial overview
- Heart and blood vessel studies
- Kidney, bone, and other conditions
- What outcomes are measured
- Who the trials include
- Trial phases and designs
Trial overview
These clinical trials study Losartan Potassium in different patient groups and disease settings.[1] The trials are not all for the same illness, and they use different study designs, such as interventional studies, placebo comparisons, and open-label research.[1]
Across the trial set, researchers are looking at whether Losartan Potassium can help with heart disease, kidney disease, bone disease, brain tumors, and inflammatory heart problems after COVID-19.[1]
Heart and blood vessel studies
Several trials focus on heart failure and related heart conditions.[3][5][7] One Phase 3 study in people with heart failure and recovered left ventricular ejection fraction compares stopping beta-blockers with continuing treatment, and Losartan appears as one of the treatment options in the study plan.[3]
Another Phase 3 trial in type 2 diabetes studies high-dose treatment with RAS-antagonists and beta-blockers to reduce cardiac death or cardiac hospitalization, and Losartan is one of the drugs listed in that treatment group.[5] A Phase 3 trial in aortic stenosis tests Losartan Potassium against placebo to see whether it slows the worsening of valve narrowing and valve calcification over 24 months.[7]
A low-intervention trial in non-ischemic cardiomyopathy studies whether stopping neurohormonal therapy is no worse than keeping it in patients who had a strong response to cardiac resynchronization therapy.[1] In this study, Losartan is one of many allowed drugs in the treatment background.[1]
A Phase 2 heart failure study also includes Losartan among many comparison treatments while testing XXB750, with the main outcome being the change in NT-proBNP at Week 16.[8]
Kidney, bone, and other conditions
Losartan Potassium is also being studied in idiopathic IgA nephropathy, which is a kidney disease where the immune system plays a role.[9] This Phase 3 trial looks at proteinuria reduction, meaning less protein in the urine, over 4 to 10 months depending on the study arm.[9]
A Phase 2 trial in osteogenesis imperfecta includes patients aged 16 years and older and measures change in CTX, a bone resorption marker, by Week 24.[6] This study aims to find an effective dose of Losartan for that patient group.[6]
A Phase 4 study called the GranStone Trial tests whether Losartan or empagliflozin can lower the risk of kidney stones and disease progression in paraffin oil induced granulomatous disease.[10] The main outcome is image-verified new or increased nephrolithiasis or nephrocalcinosis between 1 and 24 months.[10]
What outcomes are measured
The trials use different primary outcomes, which are the main results each study is built to measure.[1] In heart studies, outcomes include recurrence of left ventricular dysfunction, heart failure relapse, changes in ejection fraction, changes in left ventricular volume, NT-proBNP levels, hospitalization, and urgent treatment visits.[1][3][5][8]
In the aortic stenosis trial, researchers measure peak aortic velocity by echocardiography and valve calcification by non-contrast computed tomography after 24 months.[7] In the brain tumor study, the main outcomes are radiographic biomarkers such as relative cerebral blood flow and tissue stiffness measured in the tumor area.[4]
In kidney and bone studies, the outcomes include proteinuria, CTX, and imaging-confirmed kidney stone or calcium changes.[6][9][10]
Who the trials include
The target populations are different from one study to another.[1] Some trials include adults with heart failure or recovered ejection fraction, while others focus on people with type 2 diabetes, non-ischemic cardiomyopathy, aortic stenosis, IgA nephropathy, or paraffin oil induced granulomatous disease.[1][3][5][7][9][10]
Some studies also include patients with newly diagnosed or recurrent glioblastoma, or brain metastases from non-small-cell lung cancer.[4] One trial specifically includes older adolescents and adults aged 16 years and above with osteogenesis imperfecta.[6]
Trial phases and designs
The trial set includes Phase 2, Phase 3, Phase 4, and low-intervention research.[1] Phase 2 studies usually explore early signs of benefit and help find the right dose, while Phase 3 studies compare treatments in larger groups and look more closely at effectiveness.[4][6][7][9]
One trial is completed, several are authorised, and the study designs include interventional treatment, placebo control, and open-label testing, meaning both the researchers and participants know what treatment is given in that study.[1][2][4]
