Effect of Dotinurad in Hyperuricemia With Hypertension

NCT ID: NCT06834230

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-28
• Study Completion Date: 2030-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Dotinurad

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Febuxostat

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

URECE; Feburic

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saga University

OTHER

Sponsor Role: lead

Responsible Party

Koichi Node

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Koichi Node, Pr.,Dr.

Role: PRINCIPAL_INVESTIGATOR

Saga University

Locations

Saga University

Saga, Saga-ken, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Koichi Koichi, Pr.,Dr.

Role: CONTACT

next-diana@clin-med.org

+81-952-28-8100

Facility Contacts

Atsushi Tanaka

Role: primary

tanakaa2@cc.saga-u.ac.jp

+81-952-34-2364

Other Identifiers

00003

Identifier Type: -

Identifier Source: org_study_id