Trial Outcomes & Findings for Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities (NCT NCT00914316)
NCT ID: NCT00914316
Last Updated: 2017-08-09
Results Overview
Change in absolute walking distance in meters from baseline to 12 week follow-up treadmill test, as a percentage from baseline treadmill test
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-08-09
Participant Flow
Participant milestones
| Measure |
Phase 1-Ranolazine, Phase 2-Ranolazine
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
|
Phase 1 -Ranolazine, Phase 2 -Placebo
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Ranolazine
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Placebo
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Placebo: twice daily
|
|---|---|---|---|---|
|
Phase 1
STARTED
|
7
|
6
|
8
|
8
|
|
Phase 1
COMPLETED
|
2
|
4
|
3
|
6
|
|
Phase 1
NOT COMPLETED
|
5
|
2
|
5
|
2
|
|
Phase 2
STARTED
|
2
|
4
|
3
|
6
|
|
Phase 2
COMPLETED
|
1
|
4
|
2
|
6
|
|
Phase 2
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase 1-Ranolazine, Phase 2-Ranolazine
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
|
Phase 1 -Ranolazine, Phase 2 -Placebo
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Ranolazine
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Placebo
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Placebo: twice daily
|
|---|---|---|---|---|
|
Phase 1
Physician Decision
|
4
|
0
|
1
|
2
|
|
Phase 1
Withdrawal by Subject
|
0
|
2
|
4
|
0
|
|
Phase 1
Adverse Event
|
1
|
0
|
0
|
0
|
|
Phase 2
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities
Baseline characteristics by cohort
| Measure |
Phase 1-Ranolazine, Phase 2-Ranolazine
n=3 Participants
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
|
Phase 1 -Ranolazine, Phase 2 -Placebo
n=6 Participants
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Ranolazine
n=6 Participants
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Placebo
n=8 Participants
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Placebo: twice daily
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
77.0 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 14.9 • n=4 Participants
|
70.1 years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Missing data for 12 week test in 1 subject in Ranolazine/Ranolazine group, 1 subject in Ranolazine/placebo group, and 3 subjects in placebo/placebo group
Change in absolute walking distance in meters from baseline to 12 week follow-up treadmill test, as a percentage from baseline treadmill test
Outcome measures
| Measure |
Phase 1-Ranolazine, Phase 2-Ranolazine
n=1 Participants
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
|
Phase 1 -Ranolazine, Phase 2 -Placebo
n=3 Participants
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Ranolazine
n=3 Participants
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Placebo
n=3 Participants
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Placebo: twice daily
|
|---|---|---|---|---|
|
Percentage Increase in Absolute Walking Distance Following Phase 1
|
112 percentage of baseline
Interval 112.0 to 112.0
|
108 percentage of baseline
Interval 105.0 to 121.0
|
145 percentage of baseline
Interval 127.0 to 216.0
|
155 percentage of baseline
Interval 142.0 to 166.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Missing data from one subject 24 week treadmill test in placebo/placebo group
Change in absolute walking distance in meters from baseline to 24 week follow-up treadmill test, as a percentage from baseline treadmill test
Outcome measures
| Measure |
Phase 1-Ranolazine, Phase 2-Ranolazine
n=1 Participants
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
|
Phase 1 -Ranolazine, Phase 2 -Placebo
n=4 Participants
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Ranolazine
n=2 Participants
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Placebo
n=5 Participants
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Placebo: twice daily
|
|---|---|---|---|---|
|
Percentage Increase in Absolute Walking Distance Following Phase 2
|
98 percentage of baeline
Interval 98.0 to 98.0
|
120 percentage of baeline
Interval 107.0 to 131.0
|
181 percentage of baeline
Interval 163.0 to 200.0
|
145 percentage of baeline
Interval 121.0 to 148.0
|
Adverse Events
Phase 1-Ranolazine, Phase 2-Ranolazine
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 -Ranolazine, Phase 2 -Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 -Placebo, Phase 2 -Ranolazine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 -Placebo, Phase 2 -Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1-Ranolazine, Phase 2-Ranolazine
n=3 participants at risk
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
|
Phase 1 -Ranolazine, Phase 2 -Placebo
n=5 participants at risk
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Ranolazine
n=4 participants at risk
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Placebo: twice daily
|
Phase 1 -Placebo, Phase 2 -Placebo
n=8 participants at risk
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Placebo: twice daily
|
|---|---|---|---|---|
|
Cardiac disorders
myocardial infarction
|
33.3%
1/3 • Number of events 1 • 28 weeks
Only 8 adverse events were collected: death, unstable angina, ischemic ST depression \> 2 mm during exercise training, myocardial infarction, cerebrovascular accident, ventricular arrhythmias (non-sustained ventricular tachycardia (VT), sustained VT, ventricular fibrillation), advanced heart block (Mobitz II or Type III heart block), and congestive heart failure (CHF) requiring hospitalization. Adverse events were collected for the 20 patients completing at least baseline testing in Phase 1.
|
0.00%
0/5 • 28 weeks
Only 8 adverse events were collected: death, unstable angina, ischemic ST depression \> 2 mm during exercise training, myocardial infarction, cerebrovascular accident, ventricular arrhythmias (non-sustained ventricular tachycardia (VT), sustained VT, ventricular fibrillation), advanced heart block (Mobitz II or Type III heart block), and congestive heart failure (CHF) requiring hospitalization. Adverse events were collected for the 20 patients completing at least baseline testing in Phase 1.
|
0.00%
0/4 • 28 weeks
Only 8 adverse events were collected: death, unstable angina, ischemic ST depression \> 2 mm during exercise training, myocardial infarction, cerebrovascular accident, ventricular arrhythmias (non-sustained ventricular tachycardia (VT), sustained VT, ventricular fibrillation), advanced heart block (Mobitz II or Type III heart block), and congestive heart failure (CHF) requiring hospitalization. Adverse events were collected for the 20 patients completing at least baseline testing in Phase 1.
|
0.00%
0/8 • 28 weeks
Only 8 adverse events were collected: death, unstable angina, ischemic ST depression \> 2 mm during exercise training, myocardial infarction, cerebrovascular accident, ventricular arrhythmias (non-sustained ventricular tachycardia (VT), sustained VT, ventricular fibrillation), advanced heart block (Mobitz II or Type III heart block), and congestive heart failure (CHF) requiring hospitalization. Adverse events were collected for the 20 patients completing at least baseline testing in Phase 1.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place