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

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ClinicalTrials.gov Identifier: NCT01549977
Recruitment Status : Terminated (Business Decision (please see below))
First Posted : March 9, 2012
Results First Posted : December 20, 2013
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Angina
Interventions Drug: Febuxostat
Drug: Placebo
Enrollment 1
Recruitment Details  
Pre-assignment Details Participants with a diagnosis of chronic stable angina were enrolled in 1 of 2 treatment groups, placebo or febuxostat 80 mg once daily.
Arm/Group Title Febuxostat 80 mg Placebo
Hide Arm/Group Description Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks. Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
Period Title: Overall Study
Started 1 0
Completed 1 0
Not Completed 0 0
Arm/Group Title Febuxostat 80 mg Placebo Total
Hide Arm/Group Description Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks. Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
18 to 65 years 0 0
≥ 65 years 1 1
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female 0 0
Male 1 1
1.Primary Outcome
Title Change From Baseline in Exercise Treadmill Testing (ETT) Duration at Week 12
Hide Description The change between the duration of ETT at Week 12 relative to Baseline. ETTs were conducted using the modified Bruce Protocol. Participants exercised on a treadmill, starting at 1.7 mph and 0% incline. The intensity of exercise (speed and/or incline) was increased at 3 minute intervals.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not performed since only one participant completed the study prior to study termination.
Arm/Group Title Febuxostat 80 mg Placebo
Hide Arm/Group Description:
Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in Time to Onset of Angina During ETT at Week 12
Hide Description The change between the time to onset of angina during the exercise treadmill test (ETT) at Week 12 relative to Baseline.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not performed since only one participant completed the study prior to study termination.
Arm/Group Title Febuxostat 80 mg Placebo
Hide Arm/Group Description:
Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in Time to Onset of ≥1 mm ST-segment Depression During ETT at Week 12
Hide Description The change between the time to onset of ≥1 mm ST-segment depression during exercise treadmill test (ETT) at Week 12 relative to Baseline. ST-segment is measured by electrocardiography (ECG) and represents the interval between ventricular depolarization and repolarization.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not performed since only one participant completed the study prior to study termination.
Arm/Group Title Febuxostat 80 mg Placebo
Hide Arm/Group Description:
Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in Maximum ST-segment Depression During ETT at Week 12
Hide Description The change between the maximum ST-segment depression during ETT at Week 12 relative to Baseline. ST-segment is measured by electrocardiography (ECG) and represents the interval between ventricular depolarization and repolarization.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not performed since only one participant completed the study prior to study termination.
Arm/Group Title Febuxostat 80 mg Placebo
Hide Arm/Group Description:
Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage of Participants Stopping ETT Due to Angina at Week 12
Hide Description The percentage of participants who had to stop exercise treatment testing (ETT) due to experiencing angina symptoms at Week 12.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not performed since only one participant completed the study prior to study termination.
Arm/Group Title Febuxostat 80 mg Placebo
Hide Arm/Group Description:
Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 14 weeks.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Febuxostat 80 mg Placebo
Hide Arm/Group Description Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks. Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
All-Cause Mortality
Febuxostat 80 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Febuxostat 80 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Febuxostat 80 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   0/0 
Investigations     
Blood creatinine increased   1/1 (100.00%)  0/0 
Urinary sediment present   1/1 (100.00%)  0/0 
Indicates events were collected by systematic assessment
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.
Insufficient data to publish.
Results Point of Contact
Name/Title: Sr. VP, Clinical Science
Organization: Takeda
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01549977     History of Changes
Other Study ID Numbers: TMX-67_207
U1111-1125-1278 ( Registry Identifier: WHO )
First Submitted: March 6, 2012
First Posted: March 9, 2012
Results First Submitted: October 30, 2013
Results First Posted: December 20, 2013
Last Update Posted: December 20, 2013