RecruitingPhase 4

Effect of Dotinurad in Hyperuricemia With Hypertension

Japan360 participantsStarted 2025-03-28

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Change in CAVI

Timeframe: 24 weeks

Trial details

NCT IDNCT06834230

SponsorSaga University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Koichi Koichi, Pr.,Dr.

+81-952-28-8100 next-diana@clin-med.org

View on ClinicalTrials.gov More Hyperuricemia or Gout trials