Trial Outcomes & Findings for Effect of Febuxostat Compared to Placebo on Exercise Tolerance in Participants With Chronic Stable Angina (NCT NCT01549977)
NCT ID: NCT01549977
Last Updated: 2013-12-20
Results Overview
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.
TERMINATED
PHASE2
1 participants
Baseline and Week 12
2013-12-20
Participant Flow
Participants with a diagnosis of chronic stable angina were enrolled in 1 of 2 treatment groups, placebo or febuxostat 80 mg once daily.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Febuxostat Compared to Placebo on Exercise Tolerance in Participants With Chronic Stable Angina
Baseline characteristics by cohort
| Measure |
Febuxostat 80 mg
n=1 Participants
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
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 65 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Male
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: This analysis was not performed since only one participant completed the study prior to study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: This analysis was not performed since only one participant completed the study prior to study termination.
The change between the time to onset of angina during the exercise treadmill test (ETT) at Week 12 relative to Baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: This analysis was not performed since only one participant completed the study prior to study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: This analysis was not performed since only one participant completed the study prior to study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: This analysis was not performed since only one participant completed the study prior to study termination.
The percentage of participants who had to stop exercise treatment testing (ETT) due to experiencing angina symptoms at Week 12.
Outcome measures
Outcome data not reported
Adverse Events
Febuxostat 80 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Febuxostat 80 mg
n=1 participants at risk
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.
|
|---|---|---|
|
Investigations
Blood creatinine increased
|
100.0%
1/1 • 14 weeks.
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.
|
—
0/0 • 14 weeks.
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.
|
|
Investigations
Urinary sediment present
|
100.0%
1/1 • 14 weeks.
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.
|
—
0/0 • 14 weeks.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Insufficient data to publish.
- Publication restrictions are in place
Restriction type: OTHER