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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 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 3,236 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01151137
The ClinicalTrials.gov registry entry for NCT01151137 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 3,236 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dronedarone is the first listed.
NCT01151137 reports 0 study locations.
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.
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