NCT06834230

Effect of Dotinurad in Hyperuricemia With Hypertension

Effect of Dotinurad in Hyperuricemia With Hypertension: a Randomized Study With Febuxostat (DIANA-NEXT)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Saga University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After determining eligibility of patients for whom consent is obtained, all patients who meet the eligibility criteria will be enrolled and randomized to one of two groups: dotinurad or febuxostat. In principle, a baseline (0-week) examination will be conducted within 70days after obtaining consent, followed by 24 weeks of observation and examination. During the observation period, no changes or additions to the dosage or administration of drugs other than the study drug will be made in principle, but changes or additions will be permitted under the overall clinical judgment of the physician in charge according to the medical conditions of the study participants.

Conditions

• Hyperuricemia or Gout
• Hypertension

Interventions

Type	Name	Description
DRUG	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).
DRUG	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).

Timeline

• Start date: 2025-03-28
• Primary completion: 2027-07-31
• Completion: 2030-03-31
• First posted: 2025-02-19
• Last updated: 2025-12-15

Locations

1 site across 1 country: Japan