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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00185263
Recruitment Status : Unknown
Verified November 2008 by Cardium Therapeutics.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : November 6, 2008
Information provided by:
Cardium Therapeutics

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.

Condition or disease Intervention/treatment Phase
Stable Angina Genetic: AdF5FGF-4 vs. Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2002
Primary Completion Date : January 2005
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Genetic: AdF5FGF-4 vs. Placebo
Intracoronary infusion
Experimental: 2
Genetic: AdF5FGF-4 vs. Placebo
Intracoronary infusion
Placebo Comparator: 3
Genetic: AdF5FGF-4 vs. Placebo
Intracoronary infusion

Primary Outcome Measures :
  1. Treadmill exercise duration [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Time to coronary events [ Time Frame: 1 Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185263

Sponsors and Collaborators
Cardium Therapeutics
Study Director: Paul Foster, MD Cardium Therapeutics, 12255 El Camino Real, Suite 250, San Diego, CA 92130, USA, +1-858-436-1000

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Cardium Therapeutics
ClinicalTrials.gov Identifier: NCT00185263     History of Changes
Other Study ID Numbers: 305602
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: November 6, 2008
Last Verified: November 2008

Keywords provided by Cardium Therapeutics:
growth factor
myocardial ischemia

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms