Trial Outcomes & Findings for Ranolazine for the Treatment of Chest Pain in HCM Patients (NCT NCT01721967)
NCT ID: NCT01721967
Last Updated: 2017-03-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
60 Days
Results posted on
2017-03-03
Participant Flow
Participant milestones
| Measure |
Ranolazine
Ranolazine, 500 mg for 60 days
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ranolazine for the Treatment of Chest Pain in HCM Patients
Baseline characteristics by cohort
| Measure |
Ranolazine
n=14 Participants
Ranolazine, 500 mg for 60 days
|
|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Seattle Angina Questionnaire
Physical limitation
|
49.6 units on a scale
STANDARD_DEVIATION 18.7 • n=5 Participants
|
|
Seattle Angina Questionnaire
Anginal stability
|
45.5 units on a scale
STANDARD_DEVIATION 27.0 • n=5 Participants
|
|
Seattle Angina Questionnaire
Anginal frequency
|
65.5 units on a scale
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Seattle Angina Questionnaire
Treatment satisfaction
|
85.2 units on a scale
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Seattle Angina Questionnaire
Quality of life
|
40.9 units on a scale
STANDARD_DEVIATION 24.6 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Physical limitation
|
61.7 units on a scale
STANDARD_DEVIATION 20.6 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Symptom stability
|
43.2 units on a scale
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Symptom frequency
|
56.4 units on a scale
STANDARD_DEVIATION 20.6 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Symptom burden
|
55.3 units on a scale
STANDARD_DEVIATION 29.4 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Total symptom score
|
55.9 units on a scale
STANDARD_DEVIATION 24.2 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Self-efficacy
|
78.4 units on a scale
STANDARD_DEVIATION 21.7 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Quality of life
|
39.4 units on a scale
STANDARD_DEVIATION 26.6 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Social limitation
|
46.0 units on a scale
STANDARD_DEVIATION 31.5 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Overall summary
|
51.2 units on a scale
STANDARD_DEVIATION 22.3 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Clinical summary
|
58.8 units on a scale
STANDARD_DEVIATION 20.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 60 DaysOutcome measures
| Measure |
Ranolazine
n=11 Participants
Ranolazine, 500 mg for 60 days
|
|---|---|
|
QT Interval
|
462.8 msec
Standard Deviation 27.4
|
PRIMARY outcome
Timeframe: 60 DaysNumber of events that are considered probably or possibly related to study drug.
Outcome measures
| Measure |
Ranolazine
n=14 Participants
Ranolazine, 500 mg for 60 days
|
|---|---|
|
Number of Adverse Events Considered Probably or Possibly Related to Study Drug
|
10 adverse event
|
PRIMARY outcome
Timeframe: 60 daysTotal number of patients that tolerated 1,000mg BID dose and 500 mg BID dose
Outcome measures
| Measure |
Ranolazine
n=14 Participants
Ranolazine, 500 mg for 60 days
|
|---|---|
|
Drug Tolerability
1000 mg BID
|
9 participants
|
|
Drug Tolerability
500 mg BID
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline and 60 Days post treatmentPopulation: episodes of angina per week was not collected
Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 Days post treatmentThe Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.
Outcome measures
| Measure |
Ranolazine
n=11 Participants
Ranolazine, 500 mg for 60 days
|
|---|---|
|
Seattle Angina Questionnaire (SAQ)
Quality of life
|
70.8 units on a scale
Standard Deviation 11.3
|
|
Seattle Angina Questionnaire (SAQ)
Physical limitation
|
61.4 units on a scale
Standard Deviation 18
|
|
Seattle Angina Questionnaire (SAQ)
Anginal stability
|
90.0 units on a scale
Standard Deviation 21.1
|
|
Seattle Angina Questionnaire (SAQ)
Anginal frequency
|
86.0 units on a scale
Standard Deviation 12.7
|
|
Seattle Angina Questionnaire (SAQ)
Treatment satisfaction
|
90.6 units on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: 60 days post treatementKansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered \> 10 points and \>5 points, respectively, as previously established
Outcome measures
| Measure |
Ranolazine
n=11 Participants
Ranolazine, 500 mg for 60 days
|
|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Physical limitation
|
72 units on a scale
Standard Deviation 20.6
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Symptom stability
|
72.7 units on a scale
Standard Deviation 26.1
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Symptom frequency
|
72.2 units on a scale
Standard Deviation 20
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Symptom burden
|
75 units on a scale
Standard Deviation 24.2
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Total symptom score
|
73.6 units on a scale
Standard Deviation 21.3
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Self-efficacy
|
85.2 units on a scale
Standard Deviation 14.6
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Quality of life
|
65.2 units on a scale
Standard Deviation 25.8
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Social limitation
|
66.1 units on a scale
Standard Deviation 31.2
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Overall summary
|
69.8 units on a scale
Standard Deviation 23.5
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Clinical summary
|
74 units on a scale
Standard Deviation 20.5
|
Adverse Events
Ranolazine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ranolazine
n=14 participants at risk
Ranolazine, 500 mg for 60 days
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Leg Weakness
|
7.1%
1/14
|
|
General disorders
dizziness
|
7.1%
1/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place