RecruitingPhase 4NCT06834230
Effect of Dotinurad in Hyperuricemia With Hypertension
Effect of Dotinurad in Hyperuricemia With Hypertension: a Randomized Study With Febuxostat (DIANA-NEXT)
Sponsor
Saga University
Enrollment
360 participants
Start Date
Mar 28, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.
Eligibility
Min Age: 20 Years
Inclusion Criteria4
- Patients aged 20 years or older at the time of consent (regardless of gender)
- Patients with hyperuricemia with serum uric acid level \>7.0 mg/dL who have not received any urate lowering drug within 27 days prior to obtaining consent, or patients who were receiving urate lowering drugs at the time of obtaining consent but have been off the drugs for more than 27 days
- Hypertensive patients who meet the definition of hypertension in the latest Hypertension Treatment Guidelines of the Japanese Society of Hypertension and whose treatment for hypertension (with or without drug therapy) has not changed within 4 weeks prior to eligibility determination
- Patients who have given written consent to participate in this study
Exclusion Criteria11
- Patients with unsettled gout after acute gouty arthritis
- Patients currently suffering from urinary tract stones
- Patients with known secondary hyperuricemia who have Lesch-Nyhan syndrome, hyperphosphoribosyl pyrophosphate synthase, congenital myogenic hyperuricemia, hematopoietic tumors (acute leukemia, malignant lymphoma, myeloproliferative disorders, myelodysplastic syndrome), solid tumors (breast cancer, seminoma, sarcoma, Wilms' tumor, small cell lung cancer), non-neoplastic diseases (psoriasis vulgaris, secondary polycythemia vera, hemolytic anemia), tumor melting syndrome, rhabdomyolysis, hypothyroidism, polycystic kidney disease, lead poisoning/lead nephropathy, Down syndrome, familial juvenile gout nephropathy, hyperlactatemia, or type 1 glycogenic disease
- Patients with hypertensive emergencies and urgency
- Patients with active malignancies
- Patients with severe hepatic dysfunction
- Patients with severe renal dysfunction with oliguria or anuria
- Pregnant, possibly pregnant, or lactating patients
- Patients with a history of hypersensitivity to the components of dotinurad and febuxostat
- Patients receiving mercaptopurine hydrate or azathioprine
- Other patients deemed inappropriate for this study by the investigator
Interventions
DRUGDotinurad
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).
DRUGFebuxostat
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).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06834230
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