Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174915
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2005-09-09
Brief Title:
Phase 3 Febuxostat Allopurinol and Placebo-Controlled Study in Gout Subjects
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Randomized Multicenter Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APEX
Brief Summary:
The purpose of this study is to compare febuxostat allopurinol and placebo once daily QD in subjects with gout
Detailed Description:
A Phase 3 Study comparing 80 mg 120 mg or 240 mg of febuxostat allopurinol 300 mg for those with normal renal function and 100 mg for those with impaired renal function and placebo administered once daily in subjects with gout
Subjects will receive treatment for 28 weeks
Subjects will receive treatment for 28 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1113-9740 | REGISTRY | WHO | None |