Effect of Dotinurad in Hyperuricemia With Hypertension: a Randomized Study With Febuxostat (DIANA-NEXT)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Change in CAVI
研究概览
简要总结
The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Dotinurad (Drug)
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).
干预措施: Febuxostat (Drug)
结局指标
主要结局
Change in CAVI
时间窗: 24 weeks
Change in CAVI at 24 weeks after study drug administration
次要结局
- Change in CAVI category(12 weeks)
- Change in CAVI(12 weeks)