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Recruiting Phase 4

Effect of Dotinurad in Hyperuricemia With Hypertension

NCT06834230 · tracked via the Priya Life Science Japan tracker
Sponsor
Saga University
Phase
Phase 4
Started
2025-03-28
Last updated
2025-12-15

Condition(s) studied

Hyperuricemia or GoutHypertension

Investigational drug(s) / intervention(s)

Dotinurad →Febuxostat →

Dotinurad: 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).

Febuxostat: 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).

Study 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

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients aged 20 years or older at the time of consent (regardless of gender) 2. 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 3. 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 4. Patients who have given written consent to participate in this study Exclusion Criteria: 1. Patients with unsettled gout after acute gouty arthritis 2. Patients currently suffering from urinary tract stones 3. 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 4. Patients with hypertensive emergencies and urgency 5. Patients with active malignancies 6. Patients with severe hepatic dysfunction 7. Patients with severe renal dysfunction with oliguria or anuria 8. Pregnant, possibly pregnant, or lactating patients 9. Patients with a history of hypersensitivity to the components of dotinurad and febuxostat 10. Patients receiving mercaptopurine hydrate or azathioprine 11. Other patients deemed inappropriate for this study by the investigator

Primary outcome measure(s)

  • Change in CAVI — 24 weeks
    Change in CAVI at 24 weeks after study drug administration

Trial sites (1)

FacilityCityRegionStatus
Saga University Saga Saga-ken Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06834230 on ClinicalTrials.gov ↗ ← All trials in Japan