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

NCT ID: NCT00185263

Last Updated: 2008-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2008-11-30

Brief Summary

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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 Description

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Conditions

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Stable Angina

Keywords

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angina FGF-4 angiogenesis adenovector growth factor myocardial ischemia revascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Ad5FGF-4

Group Type EXPERIMENTAL

AdF5FGF-4 vs. Placebo

Intervention Type GENETIC

Intracoronary infusion

2

Ad5FGF-4

Group Type EXPERIMENTAL

AdF5FGF-4 vs. Placebo

Intervention Type GENETIC

Intracoronary infusion

3

Placebo

Group Type PLACEBO_COMPARATOR

AdF5FGF-4 vs. Placebo

Intervention Type GENETIC

Intracoronary infusion

Interventions

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AdF5FGF-4 vs. Placebo

Intracoronary infusion

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardium Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Cardium Therapeutics

Principal Investigators

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Paul Foster, MD

Role: STUDY_DIRECTOR

Cardium Therapeutics, 12255 El Camino Real, Suite 250, San Diego, CA 92130, USA, +1-858-436-1000

Countries

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Argentina Belgium Brazil Canada Finland Ireland Mexico Netherlands Poland Spain Sweden United Kingdom United States

References

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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.

Reference Type DERIVED
PMID: 17825712 (View on PubMed)

Other Identifiers

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305602

Identifier Type: -

Identifier Source: org_study_id