Comparison · NCT00174785-8a9b5021
Dronedarone 400mg Bid vs Placebo: First Hospitalization for Cardiovascular Reason
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. Trial comparisons, record NCT00174785-8a9b5021. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00174785-8a9b5021
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.293 | 0.275 | 0.312 | wilson | |
| Risk in group 2 | 0.369 | 0.35 | 0.389 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0758 | -0.103 | -0.0487 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.795 | 0.732 | 0.863 | log | |
| Odds ratio, group 1 over group 2 | 0.709 | 0.627 | 0.802 | log | |
| Number needed to treat, for one fewer participant with the outcome on Dronedarone 400mg Bid than on Placebo | 13.2 | 9.73 | 20.5 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Dronedarone 400mg Bid | dronedarone tablets 400mg twice daily | 675 | 2,301 | OG000 |
| Group 2 | Placebo | matching placebo tablets | 859 | 2,327 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- First Hospitalization for Cardiovascular Reason
- Description
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.
- Time frame
- minimum follow-up duration: 1 year ; maximum: 2.5 years
- Population
- All randomized patients population
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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00174785?tab=results
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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