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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Japan
Saga University Hospital
RECRUITING
Saga
Contact Information
Primary
Koichi Koichi, Pr.,Dr.
next-diana@clin-med.org
+81-952-34-2364
Time Frame
Start Date: 2025-03-28
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 360
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Saga University

This content was sourced from clinicaltrials.gov

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