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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

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, 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.

Detailed Summary:
Sponsor: Cardium Therapeutics

Current Primary Outcome: Treadmill exercise duration [ Time Frame: Week 12 ]

Original Primary Outcome: Treadmill exercise duration at 12 weeks

Current Secondary Outcome: Time to coronary events [ Time Frame: 1 Year ]

Original Secondary Outcome: Time to coronary events after 1 year

Information By: Cardium Therapeutics

Dates:
Date Received: September 10, 2005
Date Started: March 2002
Date Completion: November 2008
Last Updated: November 4, 2008
Last Verified: November 2008