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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: Clinical Trial Phase 4 study, sponsored by Sanofi.
NCT01198873 is a Phase 4 study that was terminated before completion, run by Sanofi. The registered enrollment target is 76 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Left Atrial Volume index (LAVi) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.
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 |
Why NCT01198873 stopped before completion
NCT01198873 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Dronedarone is the first listed.
NCT01198873 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01198873's enrollment target sits among peer trials
76 994th of 2000 higher than 999 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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