Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346437
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2006-06-28
Brief Title:
Efficacy and Safety of Intracoronary Ad5FGF-4 in Patients With Stable Angina AGENT-3
Sponsor:
Cardium Therapeutics
Organization:
Cardium Therapeutics
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina
Status:
COMPLETED
Status Verified Date:
2008-11
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:
None
Brief Summary:
The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing angina functional class patient symptoms quality of life and cardiovascular outcomes Two doses will be studied 287 x 108 and 287 x 109 viral particles to evaluate the dose-response of Ad5FGF-4 Short-term and long-term safety of Ad5FGF-4 will also be evaluated
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