Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 6:00 AM
Study NCT ID:
NCT01213368
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2010-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Double Blind, Randomized, Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Dronedarone (SR33589B) at 300, 400, or 600 mg BID for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2013-10
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:
None
Brief Summary:
Primary Objective:
\- To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in patients with permanent Atrial Fibrillation (AF).
Secondary Objective:
* To assess the safety and tolerability of dronedarone after repeated oral doses of 300 mg, 400 mg, or 600 mg twice daily in the selected population.
* To document SR33589 and SR35021 trough plasma levels at steady state.
\- To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in patients with permanent Atrial Fibrillation (AF).
Secondary Objective:
* To assess the safety and tolerability of dronedarone after repeated oral doses of 300 mg, 400 mg, or 600 mg twice daily in the selected population.
* To document SR33589 and SR35021 trough plasma levels at steady state.
Detailed Description:
The study period per patient is approximatively 1 month broken down as follows:
* Screening period up to 7 days,
* Treatment period of 14 days,
* Follow-up period of 10 days.
* Screening period up to 7 days,
* Treatment period of 14 days,
* Follow-up period of 10 days.
Study Oversight
Has Oversight DMC:
True
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 |
|---|---|---|---|---|
| U1111-1116-9409 | OTHER | (UTN) | View |