Trial · NCT00174785

A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation

NCT00174785, Phase 3, Completed, Sanofi; results first posted 2009-12-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation. Trials, record NCT00174785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00174785

On this page

Trial

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

Title: A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation
NCT number: NCT00174785
Status: Completed
Phases: Phase 3
Enrollment: 4,628 participants, actual
Lead sponsor: Sanofi
Conditions: Atrial Fibrillation, Atrial Flutter
Interventions: dronedarone (SR33589), placebo
First posted: 2005-09-15
Last updated: 2010-01-12
Results first posted: 2009-12-23

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	First Hospitalization for Cardiovascular Reason or Death From Any Cause	minimum follow-up duration: 1 year ; maximum: 2.5 years	The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization 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	Death From Any Cause	minimum follow-up duration: 1 year ; maximum: 2.5 years	The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Secondary	First Hospitalization for Cardiovascular Reason	minimum follow-up duration: 1 year ; maximum: 2.5 years	The considered event is the first hospitalization for cardiovascular reason, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Secondary	Cardiovascular Death	minimum follow-up duration: 1 year ; maximum: 2.5 years	The considered event is cardiovascular death, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Other	Adjudicated Cardiovascular Death	minimum follow-up duration: 1 year ; maximum: 2.5 years	The considered event is cardiovascular death, as assessed by the blinded adjudication of the Steering Committee. The analysis is performed on the time from randomization 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

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	First Hospitalization for Cardiovascular Reason or Death From Any Cause	minimum follow-up duration: 1 year ; maximum: 2.5 years	All efficacy analyses were performed on the all randomized patients population including all patients randomized irrespective of whether the patient actually received any drug or complied with the study protocol.	participants	NUMBER
SECONDARY	Death From Any Cause	minimum follow-up duration: 1 year ; maximum: 2.5 years	All randomized patients population	participants	NUMBER
SECONDARY	First Hospitalization for Cardiovascular Reason	minimum follow-up duration: 1 year ; maximum: 2.5 years	All randomized patients population	participants	NUMBER
SECONDARY	Cardiovascular Death	minimum follow-up duration: 1 year ; maximum: 2.5 years	All randomized patients population	participants	NUMBER
OTHER_PRE_SPECIFIED	Adjudicated Cardiovascular Death	minimum follow-up duration: 1 year ; maximum: 2.5 years	All randomized patients population	participants	NUMBER

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Units
First Hospitalization for Cardiovascular Reason or Death From Any Cause	Dronedarone 400mg Bid	734	participants
First Hospitalization for Cardiovascular Reason or Death From Any Cause	Placebo	917	participants
Death From Any Cause	Dronedarone 400mg Bid	116	participants
Death From Any Cause	Placebo	139	participants
First Hospitalization for Cardiovascular Reason	Dronedarone 400mg Bid	675	participants
First Hospitalization for Cardiovascular Reason	Placebo	859	participants
Cardiovascular Death	Dronedarone 400mg Bid	65	participants
Cardiovascular Death	Placebo	94	participants
Adjudicated Cardiovascular Death	Dronedarone 400mg Bid	63	participants
Adjudicated Cardiovascular Death	Placebo	90	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	2,301
Overall Study	STARTED	Placebo	2,327
Overall Study	COMPLETED	Dronedarone 400mg Bid	1,605
Overall Study	COMPLETED	Placebo	1,611
Overall Study	NOT COMPLETED	Dronedarone 400mg Bid	696
Overall Study	NOT COMPLETED	Placebo	716

Source ClinicalTrials.gov

Adverse events1,136

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	573	2,291
other	Any Gastrointestinal disorders	Gastrointestinal disorders	Placebo	478	2,313
other	Diarrhoea	Gastrointestinal disorders	Dronedarone 400mg Bid	222	2,291
other	Diarrhoea	Gastrointestinal disorders	Placebo	142	2,313
other	Nausea	Gastrointestinal disorders	Dronedarone 400mg Bid	122	2,291
other	Nausea	Gastrointestinal disorders	Placebo	71	2,313
other	Any infections and infestations	Infections and infestations	Dronedarone 400mg Bid	508	2,291
other	Any infections and infestations	Infections and infestations	Placebo	533	2,313
other	Any general disorders and administration site conditions	General disorders	Dronedarone 400mg Bid	397	2,291
other	Any general disorders and administration site conditions	General disorders	Placebo	348	2,313

1 to 10 of 1,136Source ClinicalTrials.gov

See all 1,136 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	Placebo
Total, other adverse events	Dronedarone 400mg Bid	1,584	2,291
Total, other adverse events	Placebo	1,527	2,313
Total, serious adverse events	Dronedarone 400mg Bid	456	2,291
Total, serious adverse events	Placebo	489	2,313

Source ClinicalTrials.gov

Papers10

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18031520	BACKGROUND	PubMed
19213680	RESULT	PubMed
20436046	DERIVED	PubMed
21296333	DERIVED	PubMed
21576129	DERIVED	PubMed
22770643	DERIVED	PubMed
34958366	DERIVED	PubMed
35717354	DERIVED	PubMed
40295782	DERIVED	PubMed
41865291	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 comparisons6

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

Comparison	Source
Dronedarone 400mg Bid vs Placebo: Cardiovascular Death	Trial comparisons
Dronedarone 400mg Bid vs Placebo: First Hospitalization for Cardiovascular Reason or Death From Any Cause	Trial comparisons
Dronedarone 400mg Bid vs Placebo: First Hospitalization for Cardiovascular Reason	Trial comparisons
Dronedarone 400mg Bid vs Placebo: Death From Any Cause	Trial comparisons
Dronedarone 400mg Bid vs Placebo: Adjudicated Cardiovascular Death	Trial comparisons
Dronedarone 400mg Bid 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/NCT00174785

GET https://conductscience.org/api/trials/v1/NCT00174785/events?page=2

API reference For AI assistants