Trial Outcomes & Findings for Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients (NCT NCT01648205)
NCT ID: NCT01648205
Last Updated: 2022-04-07
Results Overview
Change in QTc at 2 months on ranolazine vs. at 1 month on placebo. This was prespecified outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
1 month to 2 months
Results posted on
2022-04-07
Participant Flow
Participant milestones
| Measure |
Placebo
There were 25 subjects enrolled receiving placebo for 1 month with ECG to be obtained at baseline and at 1 month.
|
|---|---|
|
Placebo
STARTED
|
25
|
|
Placebo
COMPLETED
|
21
|
|
Placebo
NOT COMPLETED
|
4
|
|
Ranolazine
STARTED
|
23
|
|
Ranolazine
COMPLETED
|
18
|
|
Ranolazine
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Placebo
There were 25 subjects enrolled receiving placebo for 1 month with ECG to be obtained at baseline and at 1 month.
|
|---|---|
|
Placebo
Pregnancy
|
1
|
|
Placebo
Withdrawal by Subject
|
1
|
|
Placebo
Protocol Violation
|
2
|
|
Ranolazine
Death
|
1
|
|
Ranolazine
Withdrawal by Subject
|
1
|
|
Ranolazine
Protocol Violation
|
3
|
Baseline Characteristics
Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients
Baseline characteristics by cohort
| Measure |
All Participants
n=25 Participants
There were 25 subjects that started the study receiving placebo for 1 month.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 14 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
|
QTc duration
|
493 miliseconds
STANDARD_DEVIATION 55 • n=99 Participants
|
PRIMARY outcome
Timeframe: 1 month to 2 monthsChange in QTc at 2 months on ranolazine vs. at 1 month on placebo. This was prespecified outcome.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo was administered for 1 month.
|
Ranolazine at 2 Months
n=23 Participants
Ranolazine was administered after 1 month
|
|---|---|---|
|
Change in QTc Duration at 2 Months
|
503 miliseconds
Standard Deviation 46
|
497 miliseconds
Standard Deviation 47
|
SECONDARY outcome
Timeframe: 1 month to 6 monthsChange in QTc at 6 months on ranolazine vs. at 1 month on placebo. This was prespecified outcome.
Outcome measures
| Measure |
Placebo
n=23 Participants
Placebo was administered for 1 month.
|
Ranolazine at 2 Months
n=21 Participants
Ranolazine was administered after 1 month
|
|---|---|---|
|
Change in QTc at 6 Months
|
504 miliseconds
Standard Deviation 53
|
501 miliseconds
Standard Deviation 49
|
Adverse Events
Ranolazine
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranolazine
n=25 participants at risk
During 5 months on ranolazine following adverse events were reported:
Ventricular fibrillation successfully treated with shock from implantable cardioverter-defibrillator (n=1) Ventricular fibrillation unsuccessfully treated with shock from implantable cardioverter-defibrillator with subsequent death (n=1) Bundle branch block (n=1) Dizziness/unsteadiness (n=3) Headache (n=1) Constipation (n=1) Hematuria (n=1) Hemorrhoids (n=1)
|
Placebo
n=25 participants at risk
During 1 month on placebo following adverse events were reported:
Pregnancy (n=1) Gastritis (n=1) Generalized weakness (n=1)
|
|---|---|---|
|
Cardiac disorders
Ventricular Fibrillation
|
8.0%
2/25 • Number of events 2 • Adverse events data were collected for 1 month on placebo and for up to 5 months on ranolazine.
|
0.00%
0/25 • Adverse events data were collected for 1 month on placebo and for up to 5 months on ranolazine.
|
Other adverse events
| Measure |
Ranolazine
n=25 participants at risk
During 5 months on ranolazine following adverse events were reported:
Ventricular fibrillation successfully treated with shock from implantable cardioverter-defibrillator (n=1) Ventricular fibrillation unsuccessfully treated with shock from implantable cardioverter-defibrillator with subsequent death (n=1) Bundle branch block (n=1) Dizziness/unsteadiness (n=3) Headache (n=1) Constipation (n=1) Hematuria (n=1) Hemorrhoids (n=1)
|
Placebo
n=25 participants at risk
During 1 month on placebo following adverse events were reported:
Pregnancy (n=1) Gastritis (n=1) Generalized weakness (n=1)
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
12.0%
3/25 • Number of events 3 • Adverse events data were collected for 1 month on placebo and for up to 5 months on ranolazine.
|
0.00%
0/25 • Adverse events data were collected for 1 month on placebo and for up to 5 months on ranolazine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place