Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01047566
Status:
COMPLETED
Last Update Posted:
2011-11-10
First Post:
2010-01-12
Brief Title:
Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation AFRODITE
Sponsor:
Sanofi
Organization:
Sanofi
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-018215-53 | EUDRACT_NUMBER | None | None |