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Comparison · NCT00174785-37a44b44

Dronedarone 400mg Bid vs Placebo: First Hospitalization for Cardiovascular Reason or Death From Any Cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Dronedarone 400mg Bid vs Placebo: First Hospitalization for Cardiovascular Reason or Death From Any Cause. Trial comparisons, record NCT00174785-37a44b44. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00174785-37a44b44

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3190.30.338wilson
Risk in group 20.3940.3740.414wilson
Risk difference, group 1 minus group 2-0.0751-0.102-0.0475newcombe hybrid score
Risk ratio, group 1 over group 20.8090.7490.875log
Odds ratio, group 1 over group 20.720.6380.813log
Number needed to treat, for one fewer participant with the outcome on Dronedarone 400mg Bid than on Placebo13.39.7621.1from the risk difference interval

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Dronedarone 400mg Biddronedarone tablets 400mg twice daily7342,301OG000
Group 2Placebomatching placebo tablets9172,327OG001

Outcome

Type
PRIMARY
Title
First Hospitalization for Cardiovascular Reason or Death From Any Cause
Description
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.
Time frame
minimum follow-up duration: 1 year ; maximum: 2.5 years
Population
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.

Source ClinicalTrials.gov

Trial

Title
A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation
NCT number
NCT00174785
Phases
PHASE3
Conditions
Atrial Fibrillation, Atrial Flutter
Interventions
dronedarone (SR33589), placebo
Lead sponsor
Sanofi
Results first posted
2009-12-23

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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