Trial · NCT01522651

Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation

NCT01522651, Phase 2, Completed, Gilead Sciences; results first posted 2020-11-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation. Trials, record NCT01522651. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01522651

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
NCT number: NCT01522651
Status: Completed
Phases: Phase 2
Enrollment: 134 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Atrial Fibrillation
Interventions: Ranolazine, Dronedarone, Ranolazine placebo, Dronedarone placebo
First posted: 2012-01-31
Last updated: 2020-11-06
Other registries' IDs: eudract:2011-001134-42
Results first posted: 2020-11-06

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Atrial Fibrillation Burden (AFB) at Baseline	Baseline	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.
Primary	Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12	Baseline; Week 12	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.
Primary	Absolute Change From Baseline in AFB by Week 12	Baseline; Week 12	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.
Secondary	Percentage of Participants Who Had ≥ 30%, ≥ 50%, or ≥ 70% Reduction From Baseline in AFB	Week 12	AFB was defined as the total time a participant was in AT/AF expressed as a percentage of total recording time.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Atrial Fibrillation Burden (AFB) at Baseline	Baseline	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.	Percentage of total recording time	GEOMETRIC_MEAN
PRIMARY	Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12	Baseline; Week 12	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.	percent change	GEOMETRIC_MEAN
PRIMARY	Absolute Change From Baseline in AFB by Week 12	Baseline; Week 12	Participants in Full Analysis Set with available data were analyzed.	percentage of total recording time	MEAN
SECONDARY	Percentage of Participants Who Had ≥ 30%, ≥ 50%, or ≥ 70% Reduction From Baseline in AFB	Week 12	Participants in the Full Analysis Set with available data were analyzed.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group35

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Atrial Fibrillation Burden (AFB) at Baseline	Placebo	12.7	Standard Error 2.21	Percentage of total recording time
Atrial Fibrillation Burden (AFB) at Baseline	Ranolazine 750 mg	10.8	Standard Error 2.70	Percentage of total recording time
Atrial Fibrillation Burden (AFB) at Baseline	Dronedarone 225 mg	11.6	Standard Error 2.47	Percentage of total recording time
Atrial Fibrillation Burden (AFB) at Baseline	Ranolazine 750 mg + Dronedarone 225 mg	11.7	Standard Error 2.40	Percentage of total recording time
Atrial Fibrillation Burden (AFB) at Baseline	Ranolazine 750 mg + Dronedarone 150 mg	11.7	Standard Error 2.04	Percentage of total recording time
Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12	Placebo	-5.9	Standard Error 18.00	percent change
Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12	Ranolazine 750 mg	-23.0	Standard Error 21.17	percent change
Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12	Dronedarone 225 mg	3.5	Standard Error 15.68	percent change
Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12	Ranolazine 750 mg + Dronedarone 225 mg	-59.1	Standard Error 10.47	percent change
Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12	Ranolazine 750 mg + Dronedarone 150 mg	-45.5	Standard Error 10.73	percent change

1 to 10 of 35Source ClinicalTrials.gov

See all 35 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	26
Overall Study	STARTED	Ranolazine 750 mg	27
Overall Study	STARTED	Dronedarone 225 mg	26
Overall Study	STARTED	Ranolazine 750 mg + Dronedarone 225 mg	28
Overall Study	STARTED	Ranolazine 750 mg + Dronedarone 150 mg	27
Overall Study	COMPLETED	Placebo	17
Overall Study	COMPLETED	Ranolazine 750 mg	19
Overall Study	COMPLETED	Dronedarone 225 mg	22
Overall Study	COMPLETED	Ranolazine 750 mg + Dronedarone 225 mg	20
Overall Study	COMPLETED	Ranolazine 750 mg + Dronedarone 150 mg	21

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events205

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Atrial fibrillation	Cardiac disorders	Placebo	2	26
other	Atrial fibrillation	Cardiac disorders	Ranolazine 750 mg	0	26
other	Atrial fibrillation	Cardiac disorders	Dronedarone 225 mg	4	26
other	Atrial fibrillation	Cardiac disorders	Ranolazine 750 mg + Dronedarone 225 mg	1	27
other	Atrial fibrillation	Cardiac disorders	Ranolazine 750 mg + Dronedarone 150 mg	2	26
other	Vertigo	Ear and labyrinth disorders	Placebo	0	26
other	Vertigo	Ear and labyrinth disorders	Ranolazine 750 mg	3	26
other	Vertigo	Ear and labyrinth disorders	Dronedarone 225 mg	0	26
other	Vertigo	Ear and labyrinth disorders	Ranolazine 750 mg + Dronedarone 225 mg	0	27
other	Vertigo	Ear and labyrinth disorders	Ranolazine 750 mg + Dronedarone 150 mg	1	26

1 to 10 of 205Source ClinicalTrials.gov

See all 205 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	26
Total, all-cause mortality	Ranolazine 750 mg	0	26
Total, all-cause mortality	Dronedarone 225 mg	0	26
Total, all-cause mortality	Ranolazine 750 mg + Dronedarone 225 mg	0	27
Total, all-cause mortality	Ranolazine 750 mg + Dronedarone 150 mg	0	26
Total, other adverse events	Placebo	9	26
Total, other adverse events	Ranolazine 750 mg	15	26
Total, other adverse events	Dronedarone 225 mg	14	26
Total, other adverse events	Ranolazine 750 mg + Dronedarone 225 mg	12	27
Total, other adverse events	Ranolazine 750 mg + Dronedarone 150 mg	14	26

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26226999	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01522651

GET https://conductscience.org/api/trials/v1/NCT01522651/results?page=2

API reference For AI assistants