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NCT01198873 · ClinicalTrials.gov registry record · Phase 4
Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement
A Phase 4 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 4
- Development phase
- 76
- Enrollment target
NCT01198873 is a Phase 4 study that was terminated before completion, run by Sanofi. The registered enrollment target is 76 participants.
The verdict
NCT01198873, a Phase 4 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 76 participants
- Enrollment target
Study Summary
Primary Objective: \- Evaluate the effect of dronedarone versus placebo (standard therapy) in slowing the progression of adverse left atrial remodeling in patients with atrial fibrillation (AF) following 12 months of treatment. Secondary Objectives: * Evaluate the effects of dronedarone versus placebo on left atrial function; * Evaluate the effects of dronedarone versus placebo on left atrial dimension; * Evaluate the effects of dronedarone versus placebo on left ventricular function (LVEF, E, E', A, E/E') * Evaluate the safety and tolerability of dronedarone.
Interventions
- DRUG Dronedarone
- DRUG Placebo (for Dronedarone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01198873
The ClinicalTrials.gov registry entry for NCT01198873 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 76 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.
NCT01198873 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01198873 about?
NCT01198873 is a clinical study titled "Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement". Primary Objective: \- Evaluate the effect of dronedarone versus placebo (standard therapy) in slowing the progression of adverse left atrial remodeling in patients with atrial fibrillation (AF) following 12 months of treatment. Secondary Objectives: * Evaluate the effects of dronedarone versus pl...
What is the current status of trial NCT01198873?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 76 participants. The study started on 2010-09. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01198873?
The interventions under investigation include: Dronedarone (DRUG), Placebo (for Dronedarone) (DRUG).
Who is sponsoring clinical trial NCT01198873?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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