Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00185263
Status:
UNKNOWN
Last Update Posted:
2008-11-06
First Post:
2005-09-10
Brief Title:
Safety and Efficacy of Intracoronary Ad5FGF-4 in Patients With Stable Angina
Sponsor:
Cardium Therapeutics
Organization:
Cardium Therapeutics
Study Overview
Official Title:
A Multinational Multicenter Randomized Double Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina
Status:
UNKNOWN
Status Verified Date:
2008-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
AGENT-4
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 To doses are to be studied 287x108 and 287x109 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