NCT01984749Unknown不适用
A Multicenter, Randomized, Comparative Trial on the Effect of Febuxostat in Preventing Cerebral and Cardiorenovascular Events in Patients With Hyperuricemia
Freed Study Group139 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 139
- 主要终点
- Development of cerebral or cardiorenovascular events and all deaths
研究概览
简要总结
The purpose of this study is to demonstrate the effect of febuxostat in preventing cerebral and cardiorenovascular events in elderly patients with hyperuricemia who are at risk for cerebral and cardiorenovascular disease.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Patients 65 years of age or older at enrollment who are able to visit
- •(2) Patients with hyperuricemia, who have a serum uric acid level >7.0 mg/dL and <= 9.0 mg/dL (7.0 mg/dL < serum uric acid level <= 9.0 mg/dL) within 2 months prior to enrollment
- •(3) Patients at risk for any of the cerebral or cardiorenovascular diseases in i) through iv) below (i) Previous or current history of hypertension (ii) Previous or current history of type 2 diabetes mellitus (iii) Renal disorders (30 mL/min/1.73 m2 <= eGFR < 60 mL/min/1.73 m2 within 3 months prior to enrollment) (iv) Previous history of cerebral or cardiorenovascular disease for more than 3 months prior to enrollment (stroke [cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage], coronary artery disease, vascular disease, or cardiac failure)
- •(4) Patients who personally give written informed consent to participate in this study
排除标准
- •(1) Patients with gouty tophus, or patients with subjective symptoms of gouty arthritis within 1 year prior to enrollment
- •(2) Patients with a previous history of hypersensitivity to febuxostat or allopurinol
- •(3) Patients with malignant tumors
- •(4) Patients with serious kidney disease, Acute kidney disease, nephrotic syndrome, dialysis patients, kidney transplant patients, eGFR < 30 mL/min/1.73 m2 , etc.
- •(5) Patients with a previous history of acute coronary syndrome or stroke within 3 months prior to enrollment (cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage)
- •(6) Patients with a >= 50% increase in serum creatinine within 3 months prior to enrollment
- •(7) Patients with severe hypertension characterized by systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg within 3 months prior to enrollment
- •(8) Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 or more times the upper limit of normal within 3 months prior to enrollment
- •(9) Patients on any of the following medications at enrollment Mercaptopurine hydrate, azathioprine, vidarabine, or didanosine
- •(10) Patients who receive any of the following medications for the treatment of hyperuricemia within 1 month prior to enrollment Allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, or febuxostat
- •(11) Patients who start, modify the dose of, or discontinue any of the following medications within 1 month prior to enrollment Losartan, irbesartan, fenofibrate, thiazide diuretics, or loop diuretics
- •(12) Patients on hormone replacement therapy with estrogen (estrogenic hormone products)
- •(13) Patients who have participated in other clinical research (including trials) within 6 months prior to enrollment (non-interventional observational research not excluded)
- •(14) Patients otherwise judged by the principal or sub-investigator to be unsuitable for the study
研究组 & 干预措施
Febuxostat treatment group
Experimental
Once daily after breakfast (generally within 30 minutes after eating)
干预措施: Febuxostat (Drug)
结局指标
主要结局
Development of cerebral or cardiorenovascular events and all deaths
时间窗: Enrollment through Month 36
Definition of "cerebral and cardiorenovascular events": 1. Death due to cerebral or cardiorenovascular disease 2. New or recurrent cerebrovascular disease (stroke \[cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, stroke of unknown type\], transient ischemic attack 3. New or recurrent non-fatal coronary artery disease (myocardial infarction and unstable angina pectoris) 4. Cardiac failure requiring hospitalization 5. Arteriosclerotic disease requiring hospitalization (aortic aneurysm, aortic dissection, and arteriosclerosis obliterans) 6. Renal impairment (development of microalbuminuria, progression to overt proteinuria, or overt proteinuria \[≥ 300 mg/gCr\], confirmed by two consecutive laboratory tests performed after the initiation of study treatments; doubling of serum creatinine level; and progression to ESRD) 7. New atrial fibrillation (including paroxysmal atrial fibrillation) 8. Deaths that are not caused by cerebral or cardiorenovascular disease
次要结局
- Amount of change and percent change in eGFR(Enrollment through Month 36 (or withdrawal from the study))
- Blood pressure (systolic/diastolic)(Enrollment, 6, 12, 18, 24, 30, and 36 months (or withdrawal from the study))
- Occurrence of cerebral or cardiorenovascular events in the febuxostat group during the study period by febuxostat dose(Enrollment through Month 36)
- Occurrence of cerebral or cardiorenovascular event by prior history of cerebral or cardiorenovascular disease(Enrollment through Month 36)
- Amount of change and percent change in serum uric acid level(Enrollment through Month 36 (or withdrawal from the study))
- Estimated glomerular filtration rate (eGFR)(Enrollment, 4, 8, and 12 weeks and 6, 12, 18, 24, 30, and 36 months (or withdrawal from the study))
- Amount of change and percent change in quantified urinary protein(Enrollment through Month 24)
- Occurrence of cerebral or cardiorenovascular event by event(Enrollment through Month 36)
- Occurrence of cerebral or cardiorenovascular event by serum uric acid level(Enrollment through Month 36)
- Serum uric acid level(At screening, at enrollment, at 4, 8, and 12 weeks and 6, 12, 18, 24, 30, and 36 months (or at withdrawal from the study))
- Change in serum uric acid level(Enrollment through Week 4)
- Amount of change and percent change in quantitative urinary protein(Enrollment through Month 36 (or withdrawal from the study))
- Urine microalbumin-creatinine ratio(Enrollment, 6, 12, 24, and 36 months (or withdrawal from the study))
- Occurrence of adverse events(Enrollment through Month 36)
- Percent Achieving serum uric acid level of 6.0mg/dL(Enrollment to completion of study or withdrawal)
- Amount of change and percent change in urine microalbumin-creatinine ratio(Enrollment through Month 36 (or withdrawal from the study))
- Quantification of urinary protein(Enrollment, 6, 12, 24, and 36 months (or withdrawal from the study))
- Amount of change and percent change in blood pressure (systolic/diastolic)(Enrollment through Month 36 (or withdrawal from the study))
- Occurrence of cerebral or cardiorenovascular events in the non-febuxostat group during the study period by use of allopurinol(Enrollment through Month 36)
研究者
Hisao Ogawa
Deputy Director General of the hospital, National Cerebral and Cardiovascular Center Hospital
Freed Study Group
研究点 (139)
Loading locations...
相似试验
已完成
不适用
A multicenter, randomized, comparative trial on the effect of febuxostat in preventing cerebral and cardiorenovascular events in patients with hyperuricemiahyperuricemiaJPRN-UMIN000012134FREED Study Group1,000
已完成
2 期
Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate StonesHyperuricosuriaKidney StonesNCT01077284Takeda99
已完成
3 期
Febuxostat Versus Allopurinol Control Trial in Subjects With GoutGoutNCT00102440Takeda760
已完成
3 期
Efficacy and Safety of Oral Febuxostat in Participants With GoutGoutNCT00430248Takeda2,269
已完成
3 期
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative ColitisUlcerative ColitisNCT02065557AbbVie101