Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 3:39 PM
Study NCT ID:
NCT01047566
Status:
COMPLETED
Last Update Posted:
2011-11-10
First Post:
2010-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE)
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
The Effect of the Addition of Dronedarone to, Versus Increase of, Existing Conventional Rate Control Medication on Ventricular Rate During Persistent Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFRODITE
Brief Summary:
The primary objective of this study is to:
Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.
The secondary objectives of this study are to compare both study arms with regard to:
* Ventricular rate after 3 months
* Number of registered AF episodes
* Number of symptomatic AF episodes
* Severity of AF and AF-like symptoms
* Rate of premature study discontinuation
* Number of symptomatic episodes of bradycardia
* Incidence of low heart rate (\<60 bpm)
Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.
The secondary objectives of this study are to compare both study arms with regard to:
* Ventricular rate after 3 months
* Number of registered AF episodes
* Number of symptomatic AF episodes
* Severity of AF and AF-like symptoms
* Rate of premature study discontinuation
* Number of symptomatic episodes of bradycardia
* Incidence of low heart rate (\<60 bpm)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-018215-53 | EUDRACT_NUMBER | None | View |