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NCT01135017 · ClinicalTrials.gov registry record · Phase 4
Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers
A Phase 4 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 4
- Development phase
- 112
- Enrollment target
NCT01135017 is a Phase 4 study that was terminated before completion, run by Sanofi. The registered enrollment target is 112 participants.
The verdict
NCT01135017, a Phase 4 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 112 participants
- Enrollment target
Study Summary
Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker. Secondary objectives were to evaluate: * the effects of dronedarone on AF pattern characteristics i.e. ventricular rate during AF; * the effects of dronedarone on subject-perceived AF burden and symptom severity as reported by subjects using the Atrial Fibrillation Severity Scale (AFSS); * the incidence of electrical cardioversion (or overdrive pacing) during treatment; * the safety of dronedarone.
Interventions
- DRUG Dronedarone
- DRUG Placebo (for Dronedarone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01135017
The ClinicalTrials.gov registry entry for NCT01135017 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 112 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.
NCT01135017 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01135017 about?
NCT01135017 is a clinical study titled "Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers". Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker. Secondary objectives were to evaluate: * the effects of dronedarone on AF pattern characteristics i.e. ...
What is the current status of trial NCT01135017?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 112 participants. The study started on 2010-07. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01135017?
The interventions under investigation include: Dronedarone (DRUG), Placebo (for Dronedarone) (DRUG).
Who is sponsoring clinical trial NCT01135017?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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