Trial Outcomes & Findings for Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation (NCT NCT01522651)
NCT ID: NCT01522651
Last Updated: 2020-11-06
Results Overview
AFB was defined as the total time a participant was in atrial tachycardia (AT)/atrial fibrillation (AF) expressed as a percentage of total recording time. Geometric mean is the mean of log-transformed AFB exponentiated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
134 participants
Primary outcome timeframe
Baseline
Results posted on
2020-11-06
Participant Flow
Participants were enrolled at study sites in Germany, Israel, Italy, Netherlands, Poland, and the United States. The first participant was screened on 24 January 2012. The last study visit occurred on 10 March 2014.
327 participants were screened.
Participant milestones
| Measure |
Placebo
Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg
Ranolazine 750 milligrams (mg) tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Dronedarone 225 mg
Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 225 mg
Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 150 mg
Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
26
|
28
|
27
|
|
Overall Study
COMPLETED
|
17
|
19
|
22
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
4
|
8
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg
Ranolazine 750 milligrams (mg) tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Dronedarone 225 mg
Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 225 mg
Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 150 mg
Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
4
|
5
|
4
|
|
Overall Study
Cardioversion
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Device Malfunction
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Investigator's Discretion
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason Not Specified
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant Non-Compliance
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrew Consent
|
1
|
1
|
0
|
1
|
1
|
|
Overall Study
Randomized but Never Treated
|
0
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Placebo
n=26 Participants
Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg
n=26 Participants
Ranolazine 750 mg tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Dronedarone 225 mg
n=26 Participants
Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 225 mg
n=27 Participants
Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 150 mg
n=26 Participants
Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 8.4 • n=113 Participants
|
70 years
STANDARD_DEVIATION 10.8 • n=163 Participants
|
75 years
STANDARD_DEVIATION 7.8 • n=160 Participants
|
71 years
STANDARD_DEVIATION 7.1 • n=483 Participants
|
73 years
STANDARD_DEVIATION 9.4 • n=36 Participants
|
72 years
STANDARD_DEVIATION 8.8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=113 Participants
|
16 Participants
n=163 Participants
|
16 Participants
n=160 Participants
|
12 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
68 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=113 Participants
|
10 Participants
n=163 Participants
|
10 Participants
n=160 Participants
|
15 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
63 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
3 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=113 Participants
|
25 Participants
n=163 Participants
|
26 Participants
n=160 Participants
|
24 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
122 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=113 Participants
|
26 Participants
n=163 Participants
|
26 Participants
n=160 Participants
|
27 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
130 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=113 Participants
|
4 participants
n=163 Participants
|
8 participants
n=160 Participants
|
4 participants
n=483 Participants
|
2 participants
n=36 Participants
|
23 participants
n=10 Participants
|
|
Region of Enrollment
Israel
|
5 participants
n=113 Participants
|
6 participants
n=163 Participants
|
1 participants
n=160 Participants
|
6 participants
n=483 Participants
|
6 participants
n=36 Participants
|
24 participants
n=10 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=113 Participants
|
0 participants
n=163 Participants
|
0 participants
n=160 Participants
|
1 participants
n=483 Participants
|
0 participants
n=36 Participants
|
1 participants
n=10 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=113 Participants
|
0 participants
n=163 Participants
|
0 participants
n=160 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
1 participants
n=10 Participants
|
|
Region of Enrollment
Poland
|
10 participants
n=113 Participants
|
12 participants
n=163 Participants
|
11 participants
n=160 Participants
|
11 participants
n=483 Participants
|
15 participants
n=36 Participants
|
59 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=113 Participants
|
4 participants
n=163 Participants
|
6 participants
n=160 Participants
|
5 participants
n=483 Participants
|
2 participants
n=36 Participants
|
23 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The Full Analysis Set included randomized participants who received ≥ 1 dose of study drug (ranolazine, dronedarone, or placebo) and had ≥ 2 weeks (14 days) of AFB data for both the period from screening to Day 1 and following the start of treatment. Participants with available data were analyzed.
AFB was defined as the total time a participant was in atrial tachycardia (AT)/atrial fibrillation (AF) expressed as a percentage of total recording time. Geometric mean is the mean of log-transformed AFB exponentiated.
Outcome measures
| Measure |
Ranolazine 750 mg + Dronedarone 225 mg
n=20 Participants
Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 150 mg
n=22 Participants
Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
|
Placebo
n=18 Participants
Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg
n=18 Participants
Ranolazine 750 mg tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Dronedarone 225 mg
n=23 Participants
Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Atrial Fibrillation Burden (AFB) at Baseline
|
11.7 Percentage of total recording time
Standard Error 2.40
|
11.7 Percentage of total recording time
Standard Error 2.04
|
12.7 Percentage of total recording time
Standard Error 2.21
|
10.8 Percentage of total recording time
Standard Error 2.70
|
11.6 Percentage of total recording time
Standard Error 2.47
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: The Full Analysis Set included randomized participants who received ≥ 1 dose of study drug (ranolazine, dronedarone, or placebo) and had ≥ 2 weeks (14 days) of AFB data for both the period from screening to Day 1 and following the start of treatment. Participants with available data were analyzed.
AFB was defined as the total time a participant was in atrial tachycardia (AT)/atrial fibrillation (AF) expressed as a percentage of total recording time. Data are presented for baseline-adjusted AFB over 12 weeks of treatment. Geometric mean is the mean of log-transformed AFB exponentiated.
Outcome measures
| Measure |
Ranolazine 750 mg + Dronedarone 225 mg
n=20 Participants
Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 150 mg
n=22 Participants
Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
|
Placebo
n=18 Participants
Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg
n=18 Participants
Ranolazine 750 mg tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Dronedarone 225 mg
n=23 Participants
Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12
|
-59.1 percent change
Standard Error 10.47
|
-45.5 percent change
Standard Error 10.73
|
-5.9 percent change
Standard Error 18.00
|
-23.0 percent change
Standard Error 21.17
|
3.5 percent change
Standard Error 15.68
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: Participants in Full Analysis Set with available data were analyzed.
AFB is defined as the total time a participant is in AT/AF expressed as a percentage of total recording time. Data are presented for baseline-adjusted AFB over 12 weeks of treatment.
Outcome measures
| Measure |
Ranolazine 750 mg + Dronedarone 225 mg
n=20 Participants
Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 150 mg
n=22 Participants
Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
|
Placebo
n=18 Participants
Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg
n=18 Participants
Ranolazine 750 mg tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Dronedarone 225 mg
n=23 Participants
Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in AFB by Week 12
Baseline
|
16.8 percentage of total recording time
Standard Error 3.11
|
16.7 percentage of total recording time
Standard Error 3.52
|
16.8 percentage of total recording time
Standard Error 3.66
|
17.3 percentage of total recording time
Standard Error 3.74
|
19.1 percentage of total recording time
Standard Error 4.14
|
|
Absolute Change From Baseline in AFB by Week 12
Absolute Change From Baseline in AFB by Week 12
|
-4.7 percentage of total recording time
Standard Error 3.24
|
-3.9 percentage of total recording time
Standard Error 3.11
|
4.6 percentage of total recording time
Standard Error 3.19
|
-3.1 percentage of total recording time
Standard Error 2.17
|
5.6 percentage of total recording time
Standard Error 2.65
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
AFB was defined as the total time a participant was in AT/AF expressed as a percentage of total recording time.
Outcome measures
| Measure |
Ranolazine 750 mg + Dronedarone 225 mg
n=20 Participants
Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 150 mg
n=22 Participants
Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
|
Placebo
n=18 Participants
Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg
n=18 Participants
Ranolazine 750 mg tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Dronedarone 225 mg
n=23 Participants
Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Had ≥ 30%, ≥ 50%, or ≥ 70% Reduction From Baseline in AFB
≥ 30% Reduction From Baseline AFB
|
45.0 percentage of participants
|
54.5 percentage of participants
|
22.2 percentage of participants
|
50.0 percentage of participants
|
21.7 percentage of participants
|
|
Percentage of Participants Who Had ≥ 30%, ≥ 50%, or ≥ 70% Reduction From Baseline in AFB
≥ 50% Reduction From Baseline AFB
|
45.0 percentage of participants
|
54.5 percentage of participants
|
16.7 percentage of participants
|
22.2 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants Who Had ≥ 30%, ≥ 50%, or ≥ 70% Reduction From Baseline in AFB
≥ 70% Reduction From Baseline AFB
|
45.0 percentage of participants
|
27.3 percentage of participants
|
11.1 percentage of participants
|
16.7 percentage of participants
|
8.7 percentage of participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Ranolazine 750 mg
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Dronedarone 225 mg
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Ranolazine 750 mg + Dronedarone 225 mg
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Ranolazine 750 mg + Dronedarone 150 mg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=26 participants at risk
Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg
n=26 participants at risk
Ranolazine 750 mg tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Dronedarone 225 mg
n=26 participants at risk
Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 225 mg
n=27 participants at risk
Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 150 mg
n=26 participants at risk
Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
11.5%
3/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Cardiac disorders
Atrial flutter
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
General disorders
Chest pain
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Investigations
International normalised ratio increased
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Nervous system disorders
Syncope
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Vascular disorders
Hypertension
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Vascular disorders
Hypotension
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
Other adverse events
| Measure |
Placebo
n=26 participants at risk
Placebo to match ranolazine tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg
n=26 participants at risk
Ranolazine 750 mg tablet orally twice daily + placebo to match dronedarone capsule orally twice daily for 12 weeks.
|
Dronedarone 225 mg
n=26 participants at risk
Placebo to match ranolazine tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 225 mg
n=27 participants at risk
Ranolazine 750 mg tablet orally twice daily + dronedarone 225 mg capsule orally twice daily for 12 weeks.
|
Ranolazine 750 mg + Dronedarone 150 mg
n=26 participants at risk
Ranolazine 750 mg tablet orally twice daily + dronedarone 150 mg capsule orally twice daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
15.4%
4/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
11.5%
3/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
11.5%
3/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.4%
2/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
15.4%
4/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
11.5%
3/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.4%
2/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
General disorders
Asthenia
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
General disorders
Fatigue
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
11.5%
3/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.4%
2/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
General disorders
Oedema peripheral
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
11.5%
3/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.4%
2/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Infections and infestations
Urinary tract infection
|
11.5%
3/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.4%
2/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Investigations
International normalised ratio increased
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
11.5%
3/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.4%
2/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.7%
1/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Vascular disorders
Haematoma
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Vascular disorders
Hypertension
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
7.7%
2/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
|
Vascular disorders
Hypotension
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
0.00%
0/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
11.1%
3/27 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
3.8%
1/26 • Adverse Events: First dose date up to the last dose date (maximum 102 days) plus 30 days
The Safety Analysis Set included participants who received ≥1 dose of study drug (ranolazine/placebo tablets or dronedarone/placebo capsules).
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER