The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared to placebo as an add on to stable anti-anginal therapy, on the total exercise time of participants with Chronic Stable Angina.
This is a phase 2 multicenter, randomized, placebo-controlled double-blind study. This study is comprised of a single-blind placebo run-in qualifying phase lasting approximately 3 weeks and a double-blind treatment phase lasting 12 weeks. A safety follow-up visit is scheduled for 2 weeks after last dose of study drug. All participants will undergo 3 visits during a 3 week, run-in phase (Days -21 to Day 1). During the run-in phase, all participants will receive single-blind placebo. Two exercise treadmill tests (ETTs) will be conducted using the modified Bruce Protocol at Day -14 and at Day -7. The results from the Day -7 ETT will be considered as Baseline. A total of approximately 100 participants will be randomized 1:1 to receive either febuxostat 80 mg once daily (QD) or placebo QD in a double-blind treatment for 12 weeks, and 5 more visits. All participants will complete the Seattle Angina Questionnaire (SAQ) and Euroqol 5 dimension (EQ-5D) quality-of-life measurements at Day 1, Week 6 and Week 12/Early Termination (ET) Visit. The investigator will also rate the overall severity of the participant's angina at each visit based on the Canadian Cardiovascular Society Grading of Angina (CCSGA). This 12-week phase 2 proof-of-concept study was designed to assess the effect of febuxostat as an add-on to stable anti-anginal therapy on the total exercise time of participants with chronic stable angina and a serum urate ≥5 mg/dL. At this time, Takeda has decided to terminate the study for business reasons.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
Febuxostat tablets
Febuxostat placebo-matching tablets
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Carmichael, California, United States
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Fresno, California, United States
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Change From Baseline in Exercise Treadmill Testing (ETT) Duration at Week 12
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
Change From Baseline in Time to Onset of Angina During ETT at Week 12
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
Change From Baseline in Time to Onset of ≥1 mm ST-segment Depression During ETT at Week 12
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
Change From Baseline in Maximum ST-segment Depression During ETT at Week 12
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
Percentage of Participants Stopping ETT Due to Angina at Week 12
The percentage of participants who had to stop exercise treatment testing (ETT) due to experiencing angina symptoms at Week 12.
Time frame: Week 12
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Irvine, California, United States
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Paramount, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Tampa, Florida, United States
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Dunwoody, Georgia, United States
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Suwanee, Georgia, United States
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Lexington, Kentucky, United States
...and 11 more locations