Effect of Dotinurad in Hyperuricemia With Hypertension

NCT06834230 | Recruiting Phase 4

• 1 other identifier: 00003
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperuricemia or Gout; Hypertension

Keywords

Febuxostat; Dotinurad; CAVI; Arterial stiffness

Outcome Measures

Primary Outcomes (1)

• Change in CAVI

  Change in CAVI at 24 weeks after study drug administration

  24 weeks

Secondary Outcomes (3)

• Change in CAVI category

  24 weeks

• Change in CAVI

  12 weeks

• Change in CAVI category

  12 weeks

Other Outcomes (34)

• Changes in serum uric acid levels

  4, 8, 12 and 24 weeks

• Percentage of patients whose serum uric acid levels reach 6.0 mg/dL or less

  4, 8, 12 and 24 weeks

• Change in AI

  24 weeks

Study Arms (2)

Dotinurad

EXPERIMENTAL

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).

Drug: Dotinurad

Febuxostat

ACTIVE COMPARATOR

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).

Drug: Febuxostat

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).

Also known as: URECE

Dotinurad

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).

Also known as: Feburic

Febuxostat

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with unsettled gout after acute gouty arthritis
• Patients currently suffering from urinary tract stones
• 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
• Patients with hypertensive emergencies and urgency
• Patients with active malignancies
• Patients with severe hepatic dysfunction
• Patients with severe renal dysfunction with oliguria or anuria
• Pregnant, possibly pregnant, or lactating patients
• Patients with a history of hypersensitivity to the components of dotinurad and febuxostat
• Patients receiving mercaptopurine hydrate or azathioprine
• Other patients deemed inappropriate for this study by the investigator

Sponsors & Collaborators

• Saga University: lead

Study Sites (1)

Saga University

Saga, Saga-ken, 840-8502, Japan

RECRUITING

MeSH Terms

Conditions

Hyperuricemia; Gout; Hypertension

Interventions

dotinurad; Febuxostat

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Koichi Node, Pr.,Dr.

  Saga University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koichi Koichi, Pr.,Dr.

CONTACT

+81-952-28-8100; next-diana@clin-med.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Assignment

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 19, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): March 31, 2030
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

JP (1)