Trial Outcomes & Findings for Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) (NCT NCT00826280)
NCT ID: NCT00826280
Last Updated: 2024-12-03
Results Overview
Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
347 participants
Primary outcome timeframe
Day 3 and Day 5
Results posted on
2024-12-03
Participant Flow
Participant milestones
| Measure |
Placebo Plus Regadenoson
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
114
|
116
|
117
|
|
Overall Study
Safety Analysis Set
|
113
|
116
|
116
|
|
Overall Study
Completed Treatment
|
66
|
71
|
72
|
|
Overall Study
COMPLETED
|
66
|
70
|
71
|
|
Overall Study
NOT COMPLETED
|
48
|
46
|
46
|
Reasons for withdrawal
| Measure |
Placebo Plus Regadenoson
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
|---|---|---|---|
|
Overall Study
Randomized but drug not received
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Sponsor discontinued subject or study
|
1
|
0
|
0
|
|
Overall Study
Reversible ischemic defect not present
|
43
|
40
|
44
|
|
Overall Study
Interpretation Failure
|
1
|
0
|
0
|
|
Overall Study
Machine Failure
|
1
|
1
|
0
|
|
Overall Study
One or more non-interpretable scan
|
0
|
1
|
1
|
Baseline Characteristics
Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
Baseline characteristics by cohort
| Measure |
Placebo Plus Regadenoson
n=66 Participants
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
n=70 Participants
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
n=71 Participants
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 9.99 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 11.11 • n=7 Participants
|
69.4 years
STANDARD_DEVIATION 8.23 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 9.91 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
61 participants
n=5 Participants
|
63 participants
n=7 Participants
|
68 participants
n=5 Participants
|
192 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 3 and Day 5Population: The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable Myocardial Perfusion Imaging (MPI) scans. The number of participants per arm is consistent for all categories of the data table.
Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3).
Outcome measures
| Measure |
Placebo Plus Regadenoson
n=66 Participants
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
n=70 Participants
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
n=71 Participants
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
|---|---|---|---|
|
Change in Number of Reversible Defects
Baseline Stress Scan (Day 3)
|
0.67 Reversible Defects
Standard Deviation 1.377
|
1.01 Reversible Defects
Standard Deviation 1.452
|
1.00 Reversible Defects
Standard Deviation 1.595
|
|
Change in Number of Reversible Defects
Double-Blind Stress Scan (Day 5)
|
0.80 Reversible Defects
Standard Deviation 1.511
|
0.40 Reversible Defects
Standard Deviation 0.907
|
0.38 Reversible Defects
Standard Deviation 0.962
|
|
Change in Number of Reversible Defects
DoubleBlind - Baseline (Day 5 - Day 3)
|
0.12 Reversible Defects
Standard Deviation 0.981
|
-0.61 Reversible Defects
Standard Deviation 1.097
|
-0.62 Reversible Defects
Standard Deviation 1.367
|
SECONDARY outcome
Timeframe: Day 3 and Day 5Population: The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable MPI scans. The number of participants per arm is consistent for all categories of the data table.
The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD).
Outcome measures
| Measure |
Placebo Plus Regadenoson
n=66 Participants
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
n=70 Participants
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
n=71 Participants
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
|---|---|---|---|
|
Change in Summed Difference Score (SDS) Across All 17 Segments
Baseline Stress Scan (Day 3)
|
2.24 Sum Difference Score
Standard Deviation 3.013
|
2.45 Sum Difference Score
Standard Deviation 2.909
|
2.53 Sum Difference Score
Standard Deviation 3.086
|
|
Change in Summed Difference Score (SDS) Across All 17 Segments
Double-Blind Stress Scan (Day 5)
|
2.36 Sum Difference Score
Standard Deviation 3.247
|
1.42 Sum Difference Score
Standard Deviation 2.091
|
1.27 Sum Difference Score
Standard Deviation 2.003
|
|
Change in Summed Difference Score (SDS) Across All 17 Segments
DoubleBlind - Baseline (Day 5 - Day 3)
|
0.11 Sum Difference Score
Standard Deviation 2.871
|
-1.03 Sum Difference Score
Standard Deviation 2.071
|
-1.25 Sum Difference Score
Standard Deviation 2.664
|
SECONDARY outcome
Timeframe: Day 3 and Day 5Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as "N".
Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3).
Outcome measures
| Measure |
Placebo Plus Regadenoson
n=66 Participants
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
n=70 Participants
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
n=71 Participants
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
|---|---|---|---|
|
Change in Number of Reversible Defects Assessed by Computerized Quantitation
DoubleBlind - Baseline (Day 5-Day 3)[N=64; 69; 70]
|
0.31 Reversible Defects
Standard Deviation 1.622
|
-0.59 Reversible Defects
Standard Deviation 1.743
|
-0.81 Reversible Defects
Standard Deviation 1.812
|
|
Change in Number of Reversible Defects Assessed by Computerized Quantitation
Baseline Stress Scan (Day 3) [N=64; 69; 70]
|
1.47 Reversible Defects
Standard Deviation 1.927
|
2.00 Reversible Defects
Standard Deviation 2.364
|
2.19 Reversible Defects
Standard Deviation 2.122
|
|
Change in Number of Reversible Defects Assessed by Computerized Quantitation
Double-Blind Stress Scan (Day 5) [N=66; 70; 71]
|
1.74 Reversible Defects
Standard Deviation 2.355
|
1.46 Reversible Defects
Standard Deviation 1.954
|
1.42 Reversible Defects
Standard Deviation 1.794
|
SECONDARY outcome
Timeframe: Day 3 and Day 5Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as "N".
The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD).
Outcome measures
| Measure |
Placebo Plus Regadenoson
n=66 Participants
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
n=70 Participants
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
n=71 Participants
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
|---|---|---|---|
|
Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation
Baseline Stress Scan (Day 3) [N=64; 69; 70]
|
3.34 Summed Difference Score
Standard Deviation 4.383
|
4.46 Summed Difference Score
Standard Deviation 4.604
|
4.29 Summed Difference Score
Standard Deviation 4.314
|
|
Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation
Double-Blind Stress Scan (Day 5) [N=66; 70; 71]
|
4.41 Summed Difference Score
Standard Deviation 4.874
|
3.10 Summed Difference Score
Standard Deviation 4.737
|
2.46 Summed Difference Score
Standard Deviation 3.601
|
|
Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation
DoubleBlind - Baseline (Day 5-Day 3)[N=64; 69; 70]
|
1.02 Summed Difference Score
Standard Deviation 3.364
|
-1.45 Summed Difference Score
Standard Deviation 3.890
|
-1.84 Summed Difference Score
Standard Deviation 3.658
|
SECONDARY outcome
Timeframe: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as "N".
Baseline is the last non-missing measurement on or before first dose of regadenoson Change is calculated as the time point minus baseline.
Outcome measures
| Measure |
Placebo Plus Regadenoson
n=113 Participants
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
n=116 Participants
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
n=116 Participants
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
|---|---|---|---|
|
Change From Baseline in Heart Rate
Baseline [N=113; 116; 116]
|
66.0 Beats per minute
Interval 46.0 to 96.0
|
62.0 Beats per minute
Interval 45.0 to 92.0
|
64.0 Beats per minute
Interval 47.0 to 97.0
|
|
Change From Baseline in Heart Rate
Change at Day 5 (- 3 min) [N=67; 70; 71]
|
-2.0 Beats per minute
Interval -23.0 to 51.0
|
-1.0 Beats per minute
Interval -29.0 to 75.0
|
-2.0 Beats per minute
Interval -22.0 to 11.0
|
|
Change From Baseline in Heart Rate
Change at Day 5 (+3 min) [N=67; 70; 72]
|
9.0 Beats per minute
Interval -20.0 to 38.0
|
5.0 Beats per minute
Interval -23.0 to 58.0
|
0.0 Beats per minute
Interval -16.0 to 22.0
|
|
Change From Baseline in Heart Rate
Change at Day 5 (+15 min) [N=66; 72; 72]
|
4.0 Beats per minute
Interval -19.0 to 31.0
|
1.0 Beats per minute
Interval -21.0 to 63.0
|
-1.0 Beats per minute
Interval -20.0 to 25.0
|
SECONDARY outcome
Timeframe: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as "N".
Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline.
Outcome measures
| Measure |
Placebo Plus Regadenoson
n=113 Participants
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
n=116 Participants
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
n=116 Participants
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure
Baseline [N=113; 116; 116]
|
135.0 mmHg
Interval 95.0 to 184.0
|
131.0 mmHg
Interval 88.0 to 180.0
|
135.0 mmHg
Interval 100.0 to 179.0
|
|
Change From Baseline in Systolic Blood Pressure
Change at Day 5 (+15 min) [N=66; 72; 72]
|
-2.0 mmHg
Interval -37.0 to 37.0
|
8.0 mmHg
Interval -30.0 to 68.0
|
5.0 mmHg
Interval -26.0 to 46.0
|
|
Change From Baseline in Systolic Blood Pressure
Change at Day 5 (- 3 min) [N=67;70;71]
|
0.0 mmHg
Interval -26.0 to 46.0
|
12.0 mmHg
Interval -35.0 to 58.0
|
11.0 mmHg
Interval -20.0 to 46.0
|
|
Change From Baseline in Systolic Blood Pressure
Change at Day 5 (+3 min) [N=67; 70; 72]
|
0.0 mmHg
Interval -37.0 to 36.0
|
8.0 mmHg
Interval -42.0 to 52.0
|
7.5 mmHg
Interval -25.0 to 44.0
|
SECONDARY outcome
Timeframe: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as "N".
Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline.
Outcome measures
| Measure |
Placebo Plus Regadenoson
n=113 Participants
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
n=116 Participants
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
n=116 Participants
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure
Baseline [N= 113; 116;116]
|
78.0 mmHg
Interval 45.0 to 100.0
|
74.0 mmHg
Interval 48.0 to 102.0
|
73.0 mmHg
Interval 51.0 to 106.0
|
|
Change From Baseline in Diastolic Blood Pressure
Change at Day 5 (- 3 min) [N=67; 70; 71]
|
0.0 mmHg
Interval -22.0 to 14.0
|
4.0 mmHg
Interval -19.0 to 20.0
|
6.0 mmHg
Interval -12.0 to 47.0
|
|
Change From Baseline in Diastolic Blood Pressure
Change at Day 5 (+ 3 min) [N=67; 70; 72]
|
-1.0 mmHg
Interval -19.0 to 23.0
|
4.0 mmHg
Interval -20.0 to 30.0
|
3.0 mmHg
Interval -22.0 to 28.0
|
|
Change From Baseline in Diastolic Blood Pressure
Change at Day 5 (+15 min) [N=66; 72; 72]
|
-2.0 mmHg
Interval -26.0 to 18.0
|
3.0 mmHg
Interval -18.0 to 23.0
|
4.0 mmHg
Interval -16.0 to 41.0
|
Adverse Events
Placebo Plus Regadenoson
Serious events: 1 serious events
Other events: 82 other events
Deaths: 0 deaths
Caffeine 200 mg Plus Regadenoson
Serious events: 2 serious events
Other events: 89 other events
Deaths: 0 deaths
Caffeine 400 mg Plus Regadenoson
Serious events: 2 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Plus Regadenoson
n=113 participants at risk
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
n=116 participants at risk
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
n=116 participants at risk
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.88%
1/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
0.86%
1/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
0.00%
0/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
0.00%
0/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
0.86%
1/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Cardiac disorders
Myocardial infraction
|
0.00%
0/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
0.86%
1/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
0.00%
0/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Cardiac disorders
Acute myocardial infraction
|
0.00%
0/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
0.00%
0/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
0.86%
1/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Cardiac disorders
Renal failure acute
|
0.00%
0/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
0.00%
0/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
0.86%
1/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
Other adverse events
| Measure |
Placebo Plus Regadenoson
n=113 participants at risk
Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
|
Caffeine 200 mg Plus Regadenoson
n=116 participants at risk
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
Caffeine 400 mg Plus Regadenoson
n=116 participants at risk
Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
6/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
2.6%
3/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
4.3%
5/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
6/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
3.4%
4/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
4.3%
5/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Gastrointestinal disorders
Nausea
|
11.5%
13/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
13.8%
16/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
8.6%
10/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Gastrointestinal disorders
Stomach discomfort
|
6.2%
7/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
3.4%
4/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
3.4%
4/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
General disorders
Chest discomfort
|
19.5%
22/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
21.6%
25/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
16.4%
19/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
General disorders
Chest pain
|
7.1%
8/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
0.86%
1/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
1.7%
2/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Gastrointestinal disorders
Feeling hot
|
2.7%
3/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
4.3%
5/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
5.2%
6/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Nervous system disorders
Dizziness
|
19.5%
22/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
21.6%
25/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
15.5%
18/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Nervous system disorders
Dysgeusia
|
3.5%
4/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
9.5%
11/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
4.3%
5/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Nervous system disorders
Headache
|
31.9%
36/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
31.9%
37/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
32.8%
38/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
38.1%
43/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
40.5%
47/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
29.3%
34/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
|
Vascular disorders
Flushing
|
23.9%
27/113 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
25.0%
29/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
23.3%
27/116 • Beginning of Day 3 through the Day 6 visit. All Serious Adverse Events occurring until 30 days after dosing were to be reported.
Any untoward medical occurrence that occurred at the beginning of day 3 (Baseline Stress Scan) through the day 6 visit (considered "treatment- emergent") was recorded as an Adverse Event. Within a system organ class subjects may have reported more than one type of Adverse Event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER