Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476112
Status:
COMPLETED
Last Update Posted:
2008-04-02
First Post:
2007-05-18
Brief Title:
A Phase IIIII Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
Sponsor:
Advanz Pharma
Organization:
Advanz Pharma
Study Overview
Official Title:
A Phase IIIII Prospective Randomized Double-Blind Placebo-Controlled Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
Status:
COMPLETED
Status Verified Date:
2008-03
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:
Scene 2
Brief Summary:
This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter AFL to sinus rhythm
Detailed Description:
There are approximately 2 million reported prevalent cases of atrial fibrillation and atrial flutter AFL in the United States Heart Disease Stroke Statistics - 2003 Update AHA These arrhythmias may be occasional or sustained AFAFL is usually associated with age and general physical condition rather than with a specific cardiac event as is often the case with ventricular arrhythmia While not directly fatal these arrhythmias cause discomfort and can lead to stroke or congestive heart failure
This Phase IIIII trial is Cardiomes first study with RSD1235 for the treatment of atrial flutter The study seeks to demonstrate RSD1235s abilities to convert AFL to sinus rhythm The patient population will have atrial flutter of duration greater than 3 hours and less than or equal to 45 days
This is a double-blind placebo-controlled randomized study in patients with AFL stratification will be based on duration of AFL Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by Hour 15 Time 0 start of first infusion All patients will be evaluated for safety
This Phase IIIII trial is Cardiomes first study with RSD1235 for the treatment of atrial flutter The study seeks to demonstrate RSD1235s abilities to convert AFL to sinus rhythm The patient population will have atrial flutter of duration greater than 3 hours and less than or equal to 45 days
This is a double-blind placebo-controlled randomized study in patients with AFL stratification will be based on duration of AFL Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by Hour 15 Time 0 start of first infusion All patients will be evaluated for safety
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