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Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects. (APEX)

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ClinicalTrials.gov Identifier: NCT00174915
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : July 16, 2009
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gout
Interventions: Drug: Febuxostat
Drug: Allopurinol
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 167 investigative sites in the United States from 21 February 2003 to 07 April 2004.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollment in once daily (QD) treatment groups.

Reporting Groups
  Description
Febuxostat 80 mg QD Febuxostat 80 mg, orally, once daily for up to 28 weeks.
Febuxostat 120 mg QD Febuxostat 120 mg, orally, once daily for up to 28 weeks.
Febuxostat 240 mg QD Febuxostat 240 mg, orally, once daily for up to 28 weeks.
Allopurinol QD 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.
Placebo QD Placebo, orally, once daily for up to 28 weeks.

Participant Flow:   Overall Study
    Febuxostat 80 mg QD   Febuxostat 120 mg QD   Febuxostat 240 mg QD   Allopurinol QD   Placebo QD
STARTED   267   269   134   268   134 
COMPLETED   174   200   86   211   101 
NOT COMPLETED   93   69   48   57   33 
Lost to Follow-up                19                17                9                17                10 
Adverse Event                18                16                11                18                5 
Personal Reason(s)                16                16                9                9                9 
Other                15                8                6                5                3 
Gout Flare                13                6                8                1                0 
Protocol Violation                6                3                3                6                3 
Therapeutic Failure                6                3                2                1                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Febuxostat 80 mg QD Febuxostat 80 mg, orally, once daily for up to 28 weeks.
Febuxostat 120 mg QD Febuxostat 120 mg, orally, once daily for up to 28 weeks.
Febuxostat 240 mg QD Febuxostat 240 mg, orally, once daily for up to 28 weeks.
Allopurinol QD 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.
Placebo QD Placebo, orally, once daily for up to 28 weeks.
Total Total of all reporting groups

Baseline Measures
   Febuxostat 80 mg QD   Febuxostat 120 mg QD   Febuxostat 240 mg QD   Allopurinol QD   Placebo QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 267   269   134   268   134   1072 
Age, Customized 
[Units: Subjects]
           
<45 years   82   79   33   82   36   312 
45 years to <65 years   146   154   71   147   79   597 
≥65 years   39   36   30   39   19   163 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.6  (12.24)   51.2  (11.57)   54.3  (12.83)   51.8  (12.25)   51.5  (12.18)   51.6  (12.17) 
Gender 
[Units: Subjects]
           
Female   16   13   8   19   11   67 
Male   251   256   126   249   123   1005 
Race/Ethnicity, Customized 
[Units: Subjects]
           
White   200   214   107   206   108   835 
Black or African American   38   27   13   33   9   120 
Hispanic   13   16   8   17   10   64 
Asian   8   8   1   6   3   26 
Other   8   4   5   6   4   27 
Body Mass Index 
[Units: Subjects]
           
<18.5 kilogram per meter² (kg/m²)   0   0   0   0   0   0 
18.5 kg/m² to <25 kg/m²   10   11   9   15   16   61 
25 kg/m² to <30 kg/m²   85   81   42   91   48   347 
≥30 kg/m²   172   176   83   161   70   662 
missing   0   1   0   1   0   2 
Presence of a Primary PalpableTophus 
[Units: Subjects]
           
Yes   48   53   25   64   29   219 
No, but other tophi present   0   3   1   1   1   6 
No, and no other tophi present   219   213   108   203   104   847 
Serum Creatinine 
[Units: Subjects]
           
≤1.5 milligram per deciliter (mg/dL)   258   258   129   258   129   1032 
>1.5 mg/dL   9   11   5   10   5   40 


  Outcome Measures

1.  Primary:   Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).   [ Time Frame: Last 3 visits (any last 3 visits up to week 28) ]

2.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28   [ Time Frame: Week 28 ]

3.  Secondary:   Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit   [ Time Frame: Final Visit (up to 28 weeks). ]

4.  Secondary:   Percent Change From Baseline in Serum Urate Levels at Week 28.   [ Time Frame: Baseline and Week 28 ]

5.  Secondary:   Percent Change From Baseline in Serum Urate Levels at Final Visit   [ Time Frame: Baseline and Final Visit (up to 28 weeks) ]

6.  Secondary:   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.   [ Time Frame: Baseline and Week 28 ]

7.  Secondary:   Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.   [ Time Frame: Baseline and Final Visit (up to 28 weeks) ]

8.  Secondary:   Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.   [ Time Frame: Baseline and Week 28 ]

9.  Secondary:   Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit   [ Time Frame: Final Visit (up to 28 weeks) ]

10.  Secondary:   Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period.   [ Time Frame: Weeks 8 through 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research & Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications of Results:

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00174915     History of Changes
Other Study ID Numbers: C02-009
U1111-1113-9740 ( Registry Identifier: WHO )
First Submitted: September 9, 2005
First Posted: September 15, 2005
Results First Submitted: March 12, 2009
Results First Posted: July 16, 2009
Last Update Posted: February 2, 2012