search
Back to results

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

Primary Purpose

Stable Angina

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AdF5FGF-4 vs. Placebo
Sponsored by
Cardium Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina focused on measuring angina, FGF-4, angiogenesis, adenovector, growth factor, myocardial ischemia, revascularization

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Ad5FGF-4

    Ad5FGF-4

    Placebo

    Outcomes

    Primary Outcome Measures

    Treadmill exercise duration

    Secondary Outcome Measures

    Time to coronary events

    Full Information

    First Posted
    September 10, 2005
    Last Updated
    November 4, 2008
    Sponsor
    Cardium Therapeutics
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00185263
    Brief Title
    Safety and Efficacy of Intracoronary Ad5FGF-4 in Patients With Stable Angina
    Acronym
    AGENT-4
    Official Title
    A Multinational Multicenter, Randomized , Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2002 (undefined)
    Primary Completion Date
    January 2005 (Actual)
    Study Completion Date
    November 2008 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Cardium Therapeutics

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stable Angina
    Keywords
    angina, FGF-4, angiogenesis, adenovector, growth factor, myocardial ischemia, revascularization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    116 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Ad5FGF-4
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Ad5FGF-4
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Genetic
    Intervention Name(s)
    AdF5FGF-4 vs. Placebo
    Intervention Description
    Intracoronary infusion
    Primary Outcome Measure Information:
    Title
    Treadmill exercise duration
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Time to coronary events
    Time Frame
    1 Year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Foster, MD
    Organizational Affiliation
    Cardium Therapeutics, 12255 El Camino Real, Suite 250, San Diego, CA 92130, USA, +1-858-436-1000
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17825712
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs