Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
APEX
A Phase 3, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout.
2 other identifiers
interventional
1,072
0 countries
N/A
Brief Summary
The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2003
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedResults Posted
Study results publicly available
July 16, 2009
CompletedFebruary 2, 2012
January 1, 2012
1.2 years
September 9, 2005
March 12, 2009
January 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).
Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.
Last 3 visits (any last 3 visits up to week 28)
Secondary Outcomes (9)
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28
Week 28
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit
Final Visit (up to 28 weeks).
Percent Change From Baseline in Serum Urate Levels at Week 28.
Baseline and Week 28
Percent Change From Baseline in Serum Urate Levels at Final Visit
Baseline and Final Visit (up to 28 weeks)
Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.
Baseline and Week 28
- +4 more secondary outcomes
Study Arms (5)
Febuxostat 80 mg QD
EXPERIMENTALFebuxostat 120 mg QD
EXPERIMENTALFebuxostat 240 mg QD
EXPERIMENTALAllopurinol QD
ACTIVE COMPARATORPlacebo QD
PLACEBO COMPARATORInterventions
Febuxostat 80 mg, orally, once daily for up to 28 weeks.
Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine \>1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
Eligibility Criteria
You may qualify if:
- Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
- Renal function defined as a serum creatinine level of \< 2.0 mg/dL and creatinine clearance of \> 20 milliliters per minute (mL/min) by Cockroft and Gault formula.
You may not qualify if:
- History of xanthinuria
- Intolerance to allopurinol
- Presence of renal calculi,
- Alcohol intake of ≥ 14 drinks/week
- Clinically significant medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Related Publications (4)
Schumacher HR Jr, Becker MA, Wortmann RL, Macdonald PA, Hunt B, Streit J, Lademacher C, Joseph-Ridge N. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008 Nov 15;59(11):1540-8. doi: 10.1002/art.24209.
PMID: 18975369RESULTBecker MA, MacDonald PA, Hunt BJ, Lademacher C, Joseph-Ridge N. Determinants of the clinical outcomes of gout during the first year of urate-lowering therapy. Nucleosides Nucleotides Nucleic Acids. 2008 Jun;27(6):585-91. doi: 10.1080/15257770802136032.
PMID: 18600509RESULTWortmann RL, Macdonald PA, Hunt B, Jackson RL. Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. Clin Ther. 2010 Dec;32(14):2386-97. doi: 10.1016/j.clinthera.2011.01.008.
PMID: 21353107RESULTChohan S, Becker MA, MacDonald PA, Chefo S, Jackson RL. Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res (Hoboken). 2012 Feb;64(2):256-61. doi: 10.1002/acr.20680.
PMID: 22052584RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research & Development Center, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
February 1, 2003
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
February 2, 2012
Results First Posted
July 16, 2009
Record last verified: 2012-01