Trial · NCT01135017

Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers

NCT01135017, Phase 4, Terminated, Sanofi; results first posted 2013-04-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers. Trials, record NCT01135017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01135017

On this page

Trial

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

Title: Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers
NCT number: NCT01135017
Status: Terminated
Phases: Phase 4
Enrollment: 112 participants, actual
Lead sponsor: Sanofi
Conditions: Atrial Fibrillation
Interventions: Dronedarone, Placebo (for Dronedarone)
First posted: 2010-06-02
Last updated: 2013-04-11
Results first posted: 2013-04-01
Limitations and caveats: Due to smaller-than-planned number of participants (112 instead of 424), results should be cautiously interpreted. However, the power to detect large treatment effect remained high and the posthoc power to detect a 60% reduction in AF burden was 99%.

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Atrial Fibrillation (AF) Burden During the 12-week Treatment Period	Baseline (before randomization), 4 weeks and 12 weeks after randomization	AF burden, defined as the percent time a subject is in AF, was evaluated centrally by a Pacemaker Core Lab based on pacemaker interrogation reports including Electrogram (EGM) data provided by the Investigator. AF burden during the 12-week treatment period was defined as the duration-weighted average of AF burden collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing.
Secondary	AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment	4 weeks and 12 weeks after randomization	AF burden at each pacemaker interrogation as evaluated centrally by the Pacemaker Core Lab
Secondary	Average Ventricular Rate During AF Episodes	Baseline (before randomization), 4 weeks and 12 weeks after randomization	Ventricular rates of AF episodes were obtained from pacemaker interrogation and EGM review. The average ventricular rate during AF episodes in the 12-week treatment period was defined as the duration-weighted average of the ventricular rates collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing.
Secondary	Atrial Fibrillation Severity Scale (AFSS) Scores	Baseline (before randomization) and 12 weeks after randomization	The University of Toronto Atrial Fibrillation Severity Scale is an instrument to assess the subject-perceived AF burden and AF symptom severity. It consists in a questionnaire plus a scoring algorithm. AF Burden score ranges from 3 to 30 and higher scores indicate greater AF burden. AF symptoms severity score ranges from 0 to 35 and higher scores indicate extremely severe AF symptoms.
Secondary	Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)	12 weeks	Electrical cardioversion is a procedure in which an electric shock is used to restore normal heart rhythm. Overdrive pacing is a procedure in which an artificial cardiac pacemaker is used to increase the heart rate in order to suppress certain arrhythmias. Incidence rate of electrical cardioversion (or overdrive pacing) is expressed as the number of participants that was cardioverted or paced during the study.
Other	Overview of Adverse Events (AE)	from first study drug intake up to 10 days after the last study drug intake	AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Atrial Fibrillation (AF) Burden During the 12-week Treatment Period	Baseline (before randomization), 4 weeks and 12 weeks after randomization	The analysis included all randomized and treated participants with post-baseline AF burden assessment. Participants were included in the treatment group to which they were randomized (Modified Intent-to-treat analysis).	percent time in AF	GEOMETRIC_MEAN
SECONDARY	AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment	4 weeks and 12 weeks after randomization	Modified intent-to-treat population as previously defined	percent time in AF	GEOMETRIC_MEAN
SECONDARY	Average Ventricular Rate During AF Episodes	Baseline (before randomization), 4 weeks and 12 weeks after randomization	Modified intent-to-treat population as previously defined	beats/min	MEAN
SECONDARY	Atrial Fibrillation Severity Scale (AFSS) Scores	Baseline (before randomization) and 12 weeks after randomization	Modified intent-to-treat population as previously defined	units on a scale	MEAN
SECONDARY	Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)	12 weeks	Modified intent-to-treat population as previously defined	participants	NUMBER
OTHER_PRE_SPECIFIED	Overview of Adverse Events (AE)	from first study drug intake up to 10 days after the last study drug intake	All randomized and treated participants. Participants were considered according to the treatment actually received.	participants	NUMBER

Source ClinicalTrials.gov

Results by group34

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

Outcome	Group	Category	Value	Spread	Units
Atrial Fibrillation (AF) Burden During the 12-week Treatment Period	Placebo	Baseline	8.77	95% Confidence Interval 6.413 to 12.006	percent time in AF
Atrial Fibrillation (AF) Burden During the 12-week Treatment Period	Dronedarone	Baseline	10.14	95% Confidence Interval 7.167 to 14.354	percent time in AF
Atrial Fibrillation (AF) Burden During the 12-week Treatment Period	Placebo	12-week treatment period	9.90	95% Confidence Interval 6.633 to 14.772	percent time in AF
Atrial Fibrillation (AF) Burden During the 12-week Treatment Period	Dronedarone	12-week treatment period	4.63	95% Confidence Interval 2.610 to 8.198	percent time in AF
AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment	Placebo	Week 1 - 4 (n =54, 49)	8.99	95% Confidence Interval 5.901 to 13.705	percent time in AF
AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment	Dronedarone	Week 1 - 4 (n =54, 49)	3.62	95% Confidence Interval 1.806 to 7.258	percent time in AF
AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment	Placebo	Week 5 - 12 (n =54, 54)	9.37	95% Confidence Interval 5.938 to 14.786	percent time in AF
AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment	Dronedarone	Week 5 - 12 (n =54, 54)	4.28	95% Confidence Interval 2.388 to 7.673	percent time in AF
Average Ventricular Rate During AF Episodes	Placebo	Baseline (n =49, 47)	93.02	Standard Deviation 16.74	beats/min
Average Ventricular Rate During AF Episodes	Dronedarone	Baseline (n =49, 47)	90.68	Standard Deviation 19.80	beats/min

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	55
Overall Study	STARTED	Dronedarone	57
Overall Study	Treated	Placebo	55
Overall Study	Treated	Dronedarone	57
Overall Study	Evaluable for Efficacy	Placebo	55
Overall Study	Evaluable for Efficacy	Dronedarone	55
Overall Study	COMPLETED	Placebo	49
Overall Study	COMPLETED	Dronedarone	45
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Dronedarone	12

Source ClinicalTrials.gov

Adverse events36

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	Dizziness	Nervous system disorders	Placebo	2	55
other	Dizziness	Nervous system disorders	Dronedarone	3	57
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Placebo	3	55
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Dronedarone	2	57
other	Diarrhoea	Gastrointestinal disorders	Placebo	4	55
other	Diarrhoea	Gastrointestinal disorders	Dronedarone	7	57
other	Nausea	Gastrointestinal disorders	Placebo	1	55
other	Nausea	Gastrointestinal disorders	Dronedarone	7	57
other	Fatigue	General disorders	Placebo	1	55
other	Fatigue	General disorders	Dronedarone	3	57

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Dronedarone
Total, other adverse events	Placebo	9	55
Total, other adverse events	Dronedarone	16	57
Total, serious adverse events	Placebo	7	55
Total, serious adverse events	Dronedarone	7	57

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
Dronedarone vs Placebo: Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)	Trial comparisons
Dronedarone vs Placebo: serious adverse events	Trial comparisons

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/NCT01135017

GET https://conductscience.org/api/trials/v1/NCT01135017/results?page=2

API reference For AI assistants