Effect of Dotinurad in Hyperuricemia With Hypertension

Recruiting now · Phase 4

Conditions studied: Hyperuricemia or Gout, Hypertension

In brief

The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.

Key facts

Study ID

NCT06834230

Run by

Saga University

People needed

360

Starts

2025-03-28

Expected to finish

2030-03-31

Last updated by the study team

2025-12-15

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Saga University — Saga, Saga-ken, Japan (enrolling)

Full record on ClinicalTrials.gov

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