Comparing Dotinurad and Febuxostat for High Uric Acid and High Blood Pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effects of dotinurad on the cardio-ankle vascular index (CAVI) in patients suffering from hyperuricemia and hypertension, comparing it to febuxostat. Eligible participants will be randomized into two groups, receiving either dotinurad or febuxostat, with a baseline examination followed by a 24-week observation period. The study aims to assess the impact of these medications on arterial stiffness without altering other treatments during the observation phase.

Why it matters

Who can join: the full rules

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

Where it's running

• Saga University
  Saga, Saga-ken, Japan Recruiting

Study contacts

• Principal investigator: Koichi Node, Pr.,Dr. — Saga University
• Study coordinator: Koichi Koichi, Pr.,Dr.
• Email: next-diana@clin-med.org
• Phone: +81-952-28-8100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.