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

Cardium Therapeutics

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Stable Angina

Treatments: Genetic: AdF5FGF-4 vs. Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185263

305602

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CCS class II - IV, technically unsuitable for revascularization by CABG or PTCA able to exercise between 3 and 10 minutes on treadmill

Exclusion criteria

• Unstable angina, CCS class 1 angina optimal candidates for revascularization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Ad5FGF-4

Treatment:

Genetic: AdF5FGF-4 vs. Placebo

2

Experimental group

Description:

Ad5FGF-4

Treatment:

Genetic: AdF5FGF-4 vs. Placebo

3

Placebo Comparator group

Description:

Placebo

Treatment:

Genetic: AdF5FGF-4 vs. Placebo