Effect of Febuxostat Compared to Placebo on Exercise Tolerance in Participants With Chronic Stable Angina

This study has been terminated.
(Business Decision (please see below))
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01549977
First received: March 6, 2012
Last updated: October 30, 2013
Last verified: October 2013
Results First Received: October 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Angina
Interventions: Drug: Febuxostat
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of chronic stable angina were enrolled in 1 of 2 treatment groups, placebo or febuxostat 80 mg once daily.

Reporting Groups
  Description
Febuxostat 80 mg Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
Placebo Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.

Participant Flow:   Overall Study
    Febuxostat 80 mg     Placebo  
STARTED     1     0  
COMPLETED     1     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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 Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
Placebo Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Febuxostat 80 mg     Placebo     Total  
Number of Participants  
[units: participants]
  1     0     1  
Age, Customized  
[units: participants]
     
18 to 65 years     0         0  
≥ 65 years     1         1  
Gender  
[units: participants]
     
Female     0         0  
Male     1         1  



  Outcome Measures
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1.  Primary:   Change From Baseline in Exercise Treadmill Testing (ETT) Duration at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Change From Baseline in Time to Onset of Angina During ETT at Week 12   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Change From Baseline in Time to Onset of ≥1 mm ST-segment Depression During ETT at Week 12   [ Time Frame: Baseline and Week 12 ]

4.  Secondary:   Change From Baseline in Maximum ST-segment Depression During ETT at Week 12   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Percentage of Participants Stopping ETT Due to Angina at Week 12   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


No publications provided


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01549977     History of Changes
Other Study ID Numbers: TMX-67_207, U1111-1125-1278
Study First Received: March 6, 2012
Results First Received: October 30, 2013
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada