NCT00185263

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 6, 2008

Status Verified

November 1, 2008

Enrollment Period

2.8 years

First QC Date

September 10, 2005

Last Update Submit

November 4, 2008

Conditions

Stable Angina

Keywords

anginaFGF-4angiogenesisadenovectorgrowth factormyocardial ischemiarevascularization

Outcome Measures

Primary Outcomes (1)

  • Treadmill exercise duration

    Week 12

Secondary Outcomes (1)

  • Time to coronary events

    1 Year

Study Arms (3)

1

EXPERIMENTAL

Ad5FGF-4

Genetic: AdF5FGF-4 vs. Placebo

2

EXPERIMENTAL

Ad5FGF-4

Genetic: AdF5FGF-4 vs. Placebo

3

PLACEBO COMPARATOR

Placebo

Genetic: AdF5FGF-4 vs. Placebo

Interventions

AdF5FGF-4 vs. PlaceboGENETIC

Intracoronary infusion

123

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17825712DERIVED

MeSH Terms

Conditions

Angina, StableAngina PectorisMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Foster, MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

March 1, 2002

Primary Completion

January 1, 2005

Study Completion

November 1, 2008

Last Updated

November 6, 2008

Record last verified: 2008-11