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

Sponsored by:	Cardium Therapeutics
Information provided by:	Cardium Therapeutics
ClinicalTrials.gov Identifier:	NCT00185263

Purpose

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	Intervention	Phase
Stable Angina	Genetic: AdF5FGF-4 vs. Placebo	Phase II Phase III

MedlinePlus related topics: Angina Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Cardium Therapeutics:

Primary Outcome Measures:

Treadmill exercise duration [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to coronary events [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment:	116
Study Start Date:	March 2002
Estimated Study Completion Date:	November 2008
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ad5FGF-4	Genetic: AdF5FGF-4 vs. Placebo Intracoronary infusion
2: Experimental Ad5FGF-4	Genetic: AdF5FGF-4 vs. Placebo Intracoronary infusion
3: Placebo Comparator Placebo	Genetic: AdF5FGF-4 vs. Placebo Intracoronary infusion

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185263

Sponsors and Collaborators

Cardium Therapeutics

Investigators

Study Director:

Paul Foster, MD

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

More Information

Publications indexed to this study:

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. Epub 2007 Aug 24.

Responsible Party:	Cardium Therapeutics ( Chief Medical Officer )
Study ID Numbers:	305602
Study First Received:	September 10, 2005
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00185263
Health Authority:	United States: Food and Drug Administration; Argentina: Human Research Bioethics Committee; Belgium: Ministry of Social Affairs, Public Health and the Environment; Canada: Health Canada; Finland: National Agency for Medicines; Ireland: Irish Medicines Board; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cardium Therapeutics:

angina
FGF-4
angiogenesis
adenovector

growth factor
myocardial ischemia
revascularization

Study placed in the following topic categories:

Signs and Symptoms
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Angina Pectoris
Pain
Ischemia
Chest Pain

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009