Efficacy and Safety of Intracoronary Ad5FGF-4 in Patients With Stable Angina (AGENT-3)

Phase 2/3 Completed 416 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. Two doses will be studied, 2.87 x 10(8) and 2.87 x 10(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: 2001-10
Primary completion: 2005-01
Completion: 2008-11

Outcome

Missed primary endpoint

paper the primary end point change from baseline in total ETT time at 12 weeks would not reach significance. PMID 17825712 ↗

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.