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Febuxostat for Cerebral and caRdiorenovascular Events prEvEntion stuDy

NCT01984749 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2016-08-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Teijin Pharma Limited

    collaborator INDUSTRY

  • Freed Study Group

    lead OTHER

Principal Investigators

  • Hisao Ogawa · Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-10-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01984749 on ClinicalTrials.gov