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NCT01151137 · ClinicalTrials.gov registry record · Phase 3
Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 3,236
- Enrollment target
NCT01151137: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT01151137 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 3,236 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (319% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01151137, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 3,236 participants
- Enrollment target
Study Summary
Primary Objective: * Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation \[AF\] and additional risk factors Secondary Objective: * Demonstrate the efficacy of Dronedarone in preventing cardiovascular death This was an event-driven study where a common study end date \[CSED\] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).
Primary Outcome
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, Transien
Interventions
- DRUG Dronedarone
- DRUG Placebo (for Dronedarone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,236 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
Why NCT01151137 stopped before completion
NCT01151137 is an interventional study that assigns participants to a tested intervention. Its 3,236 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (319% higher).
The record links to 0 conditions, and to 2 interventions - of which Dronedarone is the first listed.
NCT01151137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01151137 about?
NCT01151137 is a clinical study titled "Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy". Primary Objective: * Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillati...
What is the current status of trial NCT01151137?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 3,236 participants. The study started on 2010-07. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01151137?
The interventions under investigation include: Dronedarone (DRUG), Placebo (for Dronedarone) (DRUG).
Who is sponsoring clinical trial NCT01151137?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01151137's enrollment target sits among peer trials
3,236 73rd of 2000 higher than 1,928 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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