A Phase 4 interventional study of Dotinurad and Febuxostat in Hyperuricemia or Gout and Hypertension, sponsored by Saga University. Recruiting at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Saga University · Phase 4, Interventional, and Treatment
The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.
After determining eligibility of patients for whom consent is obtained, all patients who meet the eligibility criteria will be enrolled and randomized to one of two groups: dotinurad or febuxostat. In principle, a baseline (0-week) examination will be conducted within 70days after obtaining consent, followed by 24 weeks of observation and examination. During the observation period, no changes or additions to the dosage or administration of drugs other than the study drug will be made in principle, but changes or additions will be permitted under the overall clinical judgment of the physician in charge according to the medical conditions of the study participants.
240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.
This study's planned enrollment of 360 is above the median of 68 across 193 interventional studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →Saga University is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Start at 0.5 mg once daily, and then referring to the attached document and the following dosage examples, gradually increase the dose to the maintenance dose (2 mg once daily).
Drug: Dotinurad
Start at 10 mg once daily, and then referring to the attached document and the following dosage examples, gradually increase the dose to the maintenance dose (40 mg once daily).
Drug: Febuxostat
Start at 0.5 mg once daily, and then referring to the attached document, gradually increase the dose to the maintenance dose (2 mg once daily).
Also known as: URECE
Start at 10 mg once daily, and then referring to the attached document, gradually increase the dose to the maintenance dose (40 mg once daily).
Also known as: Feburic
Change in CAVI
Change in CAVI at 24 weeks after study drug administration
Time frame: 24 weeks
Change in CAVI category
Change in CAVI category (\<8.0: normal, 8.0 to 9.0: borderline, 9.0 or greater: abnormal) at 24 weeks after study drug administration (key secondary endpoint)
Time frame: 24 weeks
Change in CAVI
Change in CAVI at 12 weeks after study drug administration
Time frame: 12 weeks
Change in CAVI category
Change in CAVI category (\<8.0: normal, 8.0 to 9.0: borderline, 9.0 or greater: abnormal) at 12 weeks after study drug administration
Time frame: 12 weeks
Changes in serum uric acid levels
Changes in serum uric acid levels at 4, 8, 12 and 24 weeks after study drug administration
Time frame: 4, 8, 12 and 24 weeks
Percentage of patients whose serum uric acid levels reach 6.0 mg/dL or less
Percentage of patients whose serum uric acid levels reach 6.0 mg/dL or less at 4, 8, 12, and 24 weeks after study drug administration
Time frame: 4, 8, 12 and 24 weeks
Change in AI
Change in AI at 24 weeks after study drug administration
Time frame: 24 weeks
Change in %MAP
Change in %MAP at 24 weeks after study drug administration
Time frame: 24 weeks
Change in serum NT-proBNP
Change in serum NT-proBNP at 24 weeks after study drug administration
Time frame: 24 weeks
Change in serum CRP
Change in serum CRP at 24 weeks after study drug administration
Time frame: 24 weeks
Change in serum oxidized LDL
Change in serum oxidized LDL at 24 weeks after study drug administration
Time frame: 24 weeks
Change in urinary albumin-creatinine ratio
Change in urinary albumin-creatinine ratio at 24 weeks after study drug administration
Time frame: 24 weeks
Change in urinary 8-OHdG
Change in urinary 8-OHdG at 24 weeks after study drug administration
Time frame: 24 weeks
Change in urinary NAG
Change in urinary NAG at 24 weeks after study drug administration
Time frame: 24 weeks
Changes in systolic and diastolic blood pressures
Changes in systolic and diastolic blood pressures at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes in pulse pressure (systolic blood pressure minus diastolic blood pressure)
Changes in pulse pressure (systolic blood pressure minus diastolic blood pressure) at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes in AST
Changes in AST at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes in ALT
Changes in ALT at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes inγ-GTP
Changes inγ-GTP at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes in HDL-C
Changes in HDL-C at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes in LDL-C
Changes in LDL-C at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes in TG
Changes in TG at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes in WBC (including fractions)
Changes in WBC (including fractions) at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes in PLT
Changes in PLT at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes in Cr
Changes in Cr at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes in eGFR
Changes in eGFR at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Changes in FIB-4 index
Changes FIB-4 index at 12 and 24 weeks after study drug administration
Time frame: 12 and 24 weeks
Change in echocardiographic parameters (LVEDV)
Change in LVEDV at 24 weeks after study drug administration
Time frame: 24 weeks
Changes in echocardiographic parameters (LVESV)
Changes in LVESV at 24 weeks after study drug administration
Time frame: 24 weeks
Change in echocardiographic parameters (LVEF)
Change in LVEF at 24 weeks after study drug administration
Time frame: 24 weeks
Change in echocardiographic parameters (septal e')
Change in septal e' at 24 weeks after study drug administration
Time frame: 24 weeks
Change in echocardiographic parameters (lateral e')
Change in lateral e' at 24 weeks after study drug administration
Time frame: 24 weeks
Change in echocardiographic parameters (mitral annular velocity (E))
Change in mitral annular velocity (E) at 24 weeks after study drug administration
Time frame: 24 weeks
Change in echocardiographic parameters (E/e')
Change in E/e' at 24 weeks after study drug administration
Time frame: 24 weeks
Change in echocardiographic parameters (LVMI)
Change in LVMI at 24 weeks after study drug administration
Time frame: 24 weeks
Change in echocardiographic parameters (LAVI)
Change in LAVI at 24 weeks after study drug administration
Time frame: 24 weeks
Changes in protein levels as determined by proteomics analysis
Changes in protein levels as determined by proteomics analysis(Olink Target 96 Inflammation analysis, Olink Target 96 CVDⅡ analysis, Olink Target 96 CVDⅢ analysis) at 24 weeks after study drug administration
Time frame: 24 weeks
Adverse events
Adverse events that occurred after study drug administration
Time frame: 24 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Jul 2027, 28 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Dotinurad
Saga University