Effect of dotinurad in hyperuricemia with hypertension: a randomized study with febuxostat (DIANA-NEXT)

未提供0 个研究点目标入组 360 人开始时间: 2025年3月28日最近更新: 2025年5月21日

试验速览

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•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

•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, 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 or subinvestigator.

Changes in CAVI at 24 weeks after study drug administration

change in CAVI category in the vascular insufficiency index at 24 weeks(24 weeks after treatment with study drug)
Change in CAVI category in the vascular insufficiency index at 12 weeks(12 weeks after treatment with study drug)

发起方

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