Trial · NCT00489736

Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

NCT00489736, Phase 3, Completed, Sanofi; results first posted 2009-11-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation. Trials, record NCT00489736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00489736

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Trial

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

Title: Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
NCT number: NCT00489736
Status: Completed
Phases: Phase 3
Enrollment: 504 participants, actual
Lead sponsor: Sanofi
Conditions: Atrial Fibrillation
Interventions: dronedarone (SR33589), amiodarone
First posted: 2007-06-21
Last updated: 2010-02-18
Results first posted: 2009-11-09

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Treatment Failure	minimum study duration is 6 months (+10 days); maximum is 15 months	The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The "Measured Values" table below presents the numbers of patients with the event at the end of the study period.
Secondary	Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event	minimum study duration is 6 months (+10 days); maximum is 15 months	The considered event is the occurrence of the MSE defined as thyroid, hepatic, pulmonary, neurological, skin, eye, or gastrointestinal specific treatment emergent events or premature study drug discontinuation following any adverse event (AE), whichever comes first. The analysis is performed on the time from first study drug intake to this event. The "Measured Values" table below presents the numbers of patients with the event at the end of the study period.
Other	Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting	minimum study duration is 6 months (+10 days); maximum is 15 months	The considered event is the occurrence of the MSE excluding gastrointestinal specific treatment emergent events defined as diarrhoea, nausea, vomiting. The analysis is performed on the time from first study drug intake to this event. The "Measured Values" table below presents the numbers of patients with the event at the end of the study period.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment Failure	minimum study duration is 6 months (+10 days); maximum is 15 months	All randomized and treated patients (receiving at least one dose of study drug) were included in the efficacy analysis according to the treatment received.	participants	NUMBER
SECONDARY	Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event	minimum study duration is 6 months (+10 days); maximum is 15 months	All randomized and treated patients (receiving at least one dose of study drug) were included in the safety analysis according to the treatment received.	participants	NUMBER
OTHER_PRE_SPECIFIED	Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting	minimum study duration is 6 months (+10 days); maximum is 15 months	All randomized and treated patients (receiving at least one dose of study drug) were included in the safety analysis according to the treatment received.	participants	NUMBER

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Treatment Failure	Dronedarone 400mg Bid	184	37.0 to 45.0	participants
Treatment Failure	Amiodarone 600mg/200mg od	141	99.0 to 275.0	participants
Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event	Dronedarone 400mg Bid	83		participants
Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event	Amiodarone 600mg/200mg od	107		participants
Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting	Dronedarone 400mg Bid	61		participants
Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting	Amiodarone 600mg/200mg od	99		participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Dronedarone 400mg Bid	249
Overall Study	STARTED	Amiodarone 600mg/200mg od	255
Overall Study	COMPLETED	Dronedarone 400mg Bid	153
Overall Study	COMPLETED	Amiodarone 600mg/200mg od	186
Overall Study	NOT COMPLETED	Dronedarone 400mg Bid	96
Overall Study	NOT COMPLETED	Amiodarone 600mg/200mg od	69

Source ClinicalTrials.gov

Adverse events192

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	Any Gastrointestinal disorders	Gastrointestinal disorders	Dronedarone 400mg Bid	54	249
other	Any Gastrointestinal disorders	Gastrointestinal disorders	Amiodarone 600mg/200mg od	44	255
other	Diarrhoea	Gastrointestinal disorders	Dronedarone 400mg Bid	23	249
other	Diarrhoea	Gastrointestinal disorders	Amiodarone 600mg/200mg od	8	255
other	Nausea	Gastrointestinal disorders	Dronedarone 400mg Bid	13	249
other	Nausea	Gastrointestinal disorders	Amiodarone 600mg/200mg od	9	255
other	Any Infections and infestations	Infections and infestations	Dronedarone 400mg Bid	35	249
other	Any Infections and infestations	Infections and infestations	Amiodarone 600mg/200mg od	35	255
other	Any Investigations	Investigations	Dronedarone 400mg Bid	33	249
other	Any Investigations	Investigations	Amiodarone 600mg/200mg od	35	255

1 to 10 of 192Source ClinicalTrials.gov

See all 192 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dronedarone 400mg Bid
Total, all-cause mortality	Amiodarone 600mg/200mg od
Total, other adverse events	Dronedarone 400mg Bid	146	249
Total, other adverse events	Amiodarone 600mg/200mg od	165	255
Total, serious adverse events	Dronedarone 400mg Bid	34	249
Total, serious adverse events	Amiodarone 600mg/200mg od	37	255

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
17804851	DERIVED	PubMed
20384650	DERIVED	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 comparisons4

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

Comparison	Source
Dronedarone 400mg Bid vs Amiodarone 600mg/200mg od: Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event	Trial comparisons
Dronedarone 400mg Bid vs Amiodarone 600mg/200mg od: Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting	Trial comparisons
Dronedarone 400mg Bid vs Amiodarone 600mg/200mg od: Treatment Failure	Trial comparisons
Dronedarone 400mg Bid vs Amiodarone 600mg/200mg od: 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/NCT00489736

GET https://conductscience.org/api/trials/v1/NCT00489736/events?page=2

API reference For AI assistants