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

Angina Pectoris Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00346437
Study type Interventional
Source Cardium Therapeutics
Contact
Status Completed
Phase Phase 2/Phase 3
Start date October 2001
Completion date November 2008
View Details
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