Trial · NCT01151137
Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
NCT01151137, Phase 3, Terminated, Sanofi; results first posted 2012-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy. Trials, record NCT01151137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01151137
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
- NCT number
- NCT01151137
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3,236 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Atrial Fibrillation
- Interventions
- Dronedarone, Placebo (for Dronedarone)
- First posted
- 2010-06-25
- Last updated
- 2012-10-26
- Other registries' IDs
- eudract:2010-019791-73
- Results first posted
- 2012-10-26
- Limitations and caveats
Given that the study was prematurely discontinued after 3236 patients were randomized (30% of the initial planned number), p-values were provided for information without any adjustment for multiplicity.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overview of the Two Co-primary Outcomes | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions \[MI\], or cardiovascular death. Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause. Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks \[TIA\], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause. |
| Primary | Time to First Co-primary Outcome (Cumulative Incidence Function) | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation. |
| Primary | Time to Second Co-primary Outcome (Cumulative Incidence Function) | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation. |
| Secondary | Deaths | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | Deaths were classified according to the primary cause of death. |
| Secondary | Time to Cardiovascular Death (Cumulative Incidence Function) | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | Time to cardiovascular death was defined as the time from randomization to the death. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation. |
| Other | Overview of Cardiovascular Events | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | |
| 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
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overview of the Two Co-primary Outcomes | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | Intent-to-treat population: All randomized participants considered in the treatment group to which they were randomized regardless of the treatment they actually received | participants | NUMBER |
| PRIMARY | Time to First Co-primary Outcome (Cumulative Incidence Function) | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | Intent-to-treat population as previously defined | proportion of participants | NUMBER |
| PRIMARY | Time to Second Co-primary Outcome (Cumulative Incidence Function) | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | Intent-to-treat population as previously defined | proportion of participants | NUMBER |
| SECONDARY | Deaths | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | Intent-to-treat population as previously defined | participants | NUMBER |
| SECONDARY | Time to Cardiovascular Death (Cumulative Incidence Function) | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | Intent-to-treat population as previously defined | proportion of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Overview of Cardiovascular Events | From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) | 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 | Safety population: all randomized and treated participants. Participants were considered according to the treatment actually received. Consequently the participant randomized to the placebo group who received Dronedarone was included in the Dronedarone group. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overview of the Two Co-primary Outcomes | Placebo | First co-primary endpoint | 19 | participants | |
| Overview of the Two Co-primary Outcomes | Dronedarone | First co-primary endpoint | 43 | participants | |
| Overview of the Two Co-primary Outcomes | Placebo | Second co-primary endpoint | 67 | participants | |
| Overview of the Two Co-primary Outcomes | Dronedarone | Second co-primary endpoint | 127 | participants | |
| Time to First Co-primary Outcome (Cumulative Incidence Function) | Placebo | Cumulative incidence at 14 days | 0.002 | 95% Confidence Interval 0.000 to 0.004 | proportion of participants |
| Time to First Co-primary Outcome (Cumulative Incidence Function) | Dronedarone | Cumulative incidence at 14 days | 0.009 | 95% Confidence Interval 0.005 to 0.014 | proportion of participants |
| Time to First Co-primary Outcome (Cumulative Incidence Function) | Placebo | Cumulative incidence at 30 days | 0.003 | 95% Confidence Interval 0.000 to 0.006 | proportion of participants |
| Time to First Co-primary Outcome (Cumulative Incidence Function) | Dronedarone | Cumulative incidence at 30 days | 0.013 | 95% Confidence Interval 0.008 to 0.019 | proportion of participants |
| Time to First Co-primary Outcome (Cumulative Incidence Function) | Placebo | Cumulative incidence at 90 days | 0.007 | 95% Confidence Interval 0.003 to 0.012 | proportion of participants |
| Time to First Co-primary Outcome (Cumulative Incidence Function) | Dronedarone | Cumulative incidence at 90 days | 0.021 | 95% Confidence Interval 0.014 to 0.029 | proportion of participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 1,617 | |
| Overall Study | STARTED | Dronedarone | 1,619 | |
| Overall Study | Treated | Placebo | 1,610 | |
| Overall Study | Treated | Dronedarone | 1,613 | |
| Overall Study | Discontinued Treatment | Placebo | 171 | |
| Overall Study | Discontinued Treatment | Dronedarone | 342 | |
| Overall Study | COMPLETED | Placebo | 1,601 | |
| Overall Study | COMPLETED | Dronedarone | 1,591 | |
| Overall Study | NOT COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | Dronedarone | 28 |
Source ClinicalTrials.gov
Adverse events308
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 | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 38 | 1,609 | |
| other | Diarrhoea | Gastrointestinal disorders | Dronedarone | 100 | 1,614 | |
| serious | Bronchitis | Infections and infestations | Placebo | 1 | 1,609 | |
| serious | Bronchitis | Infections and infestations | Dronedarone | 2 | 1,614 | |
| serious | Urinary tract infection | Infections and infestations | Placebo | 2 | 1,609 | |
| serious | Urinary tract infection | Infections and infestations | Dronedarone | 2 | 1,614 | |
| serious | Pneumonia | Infections and infestations | Placebo | 9 | 1,609 | |
| serious | Pneumonia | Infections and infestations | Dronedarone | 10 | 1,614 | |
| serious | Gastroenteritis | Infections and infestations | Placebo | 0 | 1,609 | |
| serious | Gastroenteritis | Infections and infestations | Dronedarone | 3 | 1,614 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse 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 | 38 | 1,609 |
| Total, other adverse events | Dronedarone | 100 | 1,614 |
| Total, serious adverse events | Placebo | 77 | 1,609 |
| Total, serious adverse events | Dronedarone | 113 | 1,614 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dronedarone vs Placebo: serious adverse events |
Source 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.
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/NCT01151137
GET https://conductscience.org/api/trials/v1/NCT01151137/results?page=2