Trial Outcomes & Findings for Effects of Ranolazine and Exercise on Daily Physical Activity Trial (NCT NCT01948310)
NCT ID: NCT01948310
Last Updated: 2017-12-12
Results Overview
This test involves exercising on a treadmill or bike to maximal exertion, during which the subject's breathing and oxygen consumption are measured. Under a set study protocol, treadmill or bike workload will increase every minute until the participant either chooses to end the test or the study personnel choose to end the test for safety purposes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
38 participants
Primary outcome timeframe
Baseline, Week 2 and Week 14
Results posted on
2017-12-12
Participant Flow
Thirty-eight subjects were recruited for this study. One dropped out before randomization.
Participant milestones
| Measure |
Placebo Plus Exercise
Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
Placebo: Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day
|
Ranolazine Plus Exercise
Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
Ranolazine: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day
Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Ranolazine and Exercise on Daily Physical Activity Trial
Baseline characteristics by cohort
| Measure |
Placebo Plus Exercise
n=19 Participants
Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
Placebo: Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day
|
Ranolazine Plus Exercise
n=18 Participants
Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
Ranolazine: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day
Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2 and Week 14Population: Subjects who completed the study were included in the analysis
This test involves exercising on a treadmill or bike to maximal exertion, during which the subject's breathing and oxygen consumption are measured. Under a set study protocol, treadmill or bike workload will increase every minute until the participant either chooses to end the test or the study personnel choose to end the test for safety purposes.
Outcome measures
| Measure |
Placebo Plus Exercise
n=16 Participants
Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
|
Ranolazine Plus Exercise
n=13 Participants
Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
|
|---|---|---|
|
Change in Peak Oxygen Consumption (VO2 Max)
Change at 2 weeks
|
0.03 ml/kg/min
Standard Deviation 1.2
|
0.38 ml/kg/min
Standard Deviation 1.9
|
|
Change in Peak Oxygen Consumption (VO2 Max)
Change at 14 weeks
|
0.9 ml/kg/min
Standard Deviation 1.5
|
2.1 ml/kg/min
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline, Week 2 and Week 14Population: Subjects who completed the study were included in the analysis
The Treatment Satisfaction scale is one of five scales of the Seattle Angina Questionnaire. The possible range of scores is 0 to 100, with higher scores indicating better quality of life.
Outcome measures
| Measure |
Placebo Plus Exercise
n=16 Participants
Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
|
Ranolazine Plus Exercise
n=13 Participants
Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
|
|---|---|---|
|
Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire
2-0 Weeks
|
0.8 units on a scale
Standard Deviation 9.1
|
5.3 units on a scale
Standard Deviation 8.0
|
|
Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire
14-0 weeks
|
3.1 units on a scale
Standard Deviation 13.3
|
-1.0 units on a scale
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Week 1, Week 4 and Week 14Population: Subjects who completed the study were included in the analysis.
Total daily physical activity is measured via Actigraph GT3X accelerometers. Accelerometers will be worn for 7 days pre-drug, post-drug/pre-exercise (week 4) and again in the final month of the exercise intervention (week 13)
Outcome measures
| Measure |
Placebo Plus Exercise
n=16 Participants
Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
|
Ranolazine Plus Exercise
n=13 Participants
Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
|
|---|---|---|
|
Change in Total Daily Energy Expenditure
2-0 weeks
|
2.0 kj/hr
Standard Deviation 39.3
|
-7.6 kj/hr
Standard Deviation 29.3
|
|
Change in Total Daily Energy Expenditure
14-0 weeks
|
22.2 kj/hr
Standard Deviation 54.2
|
24.3 kj/hr
Standard Deviation 29.9
|
Adverse Events
Ranolazine Plus Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Plus Exercise
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ranolazine Plus Exercise
n=18 participants at risk
Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
Ranolazine: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day
Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
|
Placebo Plus Exercise
n=19 participants at risk
Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.
Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
Placebo: Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day
|
|---|---|---|
|
Cardiac disorders
mild myocardial infarction
|
0.00%
0/18 • Adverse events were collected from baseline until Week 14.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from baseline until Week 14.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place