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

C

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

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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