Compares dotinurad and febuxostat in people with high uric acid and high blood pressure
Compares dotinurad with febuxostat in adults with high uric acid and hypertension.
Plain-language title generated from the registry record
Registry title: Effect of Dotinurad in Hyperuricemia With Hypertension
Key facts
- Where
- Saga, JapanSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high uric acid in the blood (hyperuricemia) who also have high blood pressure. It compares dotinurad with febuxostat.
- Age
- 20 years or older
- Sex
- Men and women can join.
- Disease stage
- Serum uric acid level above 7.0 mg/dL, and high blood pressure as defined by the latest Japanese Society of Hypertension guidelines.
- Earlier treatment
- No urate lowering drug in the 27 days before consent. Blood pressure treatment (with or without drugs) must not have changed in the 4 weeks before eligibility determination.
- Biomarker or test result
- Serum uric acid level above 7.0 mg/dL.
Main reasons for not taking part
- Unsettled gout after an acute gout attack
- Current urinary tract stones
- Known secondary hyperuricemia from other diseases, such as cancers of the blood or Down syndrome
- Hypertensive emergency or urgency, active cancer, severe liver problems, or severe kidney problems with little or no urine
- Pregnant, possibly pregnant, or breastfeeding
Read by machine on 12 November 2026.
Where in Japan
- Saga UniversitySaga, JapanContact: Atsushi TanakaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Saga University
- Trial code
- NCT06834230
- Record updated
- 15 December 2025
- Original description
The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.Read full original descriptionShow less
Effect of Dotinurad in Hyperuricemia With Hypertension: a Randomized Study With Febuxostat (DIANA-NEXT)
The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.
Inclusion: 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: Patients receiving mercaptopurine hydrate or azathioprine; 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 active malignancies; Patients with a history of hypersensitivity to the components of dotinurad and febuxostat; Patients with unsettled gout after acute gouty arthritis; Patients currently suffering from urinary tract stones; Patients with hypertensive emergencies and urgency; Patients with severe hepatic dysfunction; Patients with severe renal dysfunction with oliguria or anuria; Pregnant, possibly pregnant, or lactating patients; Other patients deemed inappropriate for this study by the investigator.