Safety and Efficacy of Intracoronary Ad5FGF-4 in Patients With Stable Angina

Phase 2/3 Unknown 116 enrolled Cardium Therapeutics

RandomizedParallel-groupQuadruple-blindTreatment

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, 2.87x10(8) and 2.87x10(9) viral particles, to evaluate the dose-response of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.

Timeline

Start: 2002-03
Primary completion: 2005-01
Completion: 2008-11

Publications

Henry TD, Grines CL, Watkins MW, Dib N, Barbeau G, Moreadith R, Andrasfay T, Engler RL. Effects of Ad5FGF-4 in patients with angina: an analysis of pooled data from the AGENT-3 and AGENT-4 trials. J Am Coll Cardiol. 2007 Sep 11;50(11):1038-46. doi: 10.1016/j.jacc.2007.06.010. Epub 2007 Aug 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ad5FGF-4	Unknown	2.87e+08 vg	Other
Subject	Ad5FGF-4	Unknown	2.87e+09 vg	Other

Indications

No indication recorded.