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RECRUITINGPhase 4INTERVENTIONAL

Effect of Dotinurad in Hyperuricemia With Hypertension

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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).

Locations (1)

Saga University
Saga, Saga-ken, Japan