NCT01984749

Febuxostat for Cerebral and caRdiorenovascular Events prEvEntion stuDy

A Multicenter, Randomized, Comparative Trial on the Effect of Febuxostat in Preventing Cerebral and Cardiorenovascular Events in Patients With Hyperuricemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Freed Study Group · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hyperuricemia

Interventions

Type	Name	Description
DRUG	Febuxostat	Febuxostat will be taken once daily after breakfast (generally within 30 minutes after eating) but can be taken around the time of breakfast even if no food has been eaten. When the dose is to be increased, the principal or sub-investigator will carry out any required examinations and tests as needed. 1. The starting dose of the investigational product (febuxostat) will be 10 mg/day. 2. The dose will be increased to 20 mg/day at Week 4. 3. The aim is to increase the dose to 40 mg/day at Week 8.

Timeline

• Start date: 2013-11-01
• Primary completion: 2017-10-01
• First posted: 2013-11-15
• Last updated: 2016-08-26

Locations

140 sites across 1 country: Japan