NCT06834230RecruitingPhase 4
Effect of Dotinurad in Hyperuricemia With Hypertension
Effect of Dotinurad in Hyperuricemia With Hypertension: a Randomized Study With Febuxostat (DIANA-NEXT)
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 28 Mar 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Saga University
- Diseases
- High blood pressure
- NCT number
- NCT06834230
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 360
- From 28 Mar 2025 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving mercaptopurine hydrate or azathioprine
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saga University Coordinator of this site? Confirm its status | Saga | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.