Effect of Dotinurad in Hyperuricemia With Hypertension

Sponsor
Saga University
Study ID
NCT06834230
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dotinurad — DRUG
    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 — DRUG
    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 Details

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 Dates

Start date
Mar 28, 2025
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Mar 31, 2030

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dotinurad
    Start at 0.5 mg once daily, and then referring to the attached document and the following dosage examples, gradually increase the dose to the maintenance dose (2 mg once daily).
  • Active Comparator: Febuxostat
    Start at 10 mg once daily, and then referring to the attached document and the following dosage examples, gradually increase the dose to the maintenance dose (40 mg once daily).

Primary Outcome Measure

Change in CAVI [ Time Frame: 24 weeks ]

Central Contacts

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