A multicenter, randomized, comparative trial on the effect of febuxostat in preventing cerebral and cardiorenovascular events in patients with hyperuricemia

Not Applicable

• Conditions: hyperuricemia

• Registration Number: JPRN-UMIN000012134
• Lead Sponsor: FREED Study Group

Brief Summary

ric acid level lowering by febuxostat provides clinical benefit for prevention of cerebral, cardiovascular, and renal events in elderly patients with hyperuricemia. Febuxostat may be expected to prevent the development and progression of chronic kidney disease. However, excessive lowering treatment by febuxostat may be avoided.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-28
• Study Completion: 2017-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

(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 AST or 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified