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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Cardium Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Cardium Therapeutics
ClinicalTrials.gov Identifier:
NCT00185263
First received: September 10, 2005
Last updated: November 4, 2008
Last verified: November 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
Experimental: 1
Ad5FGF-4
Genetic: AdF5FGF-4 vs. Placebo
Intracoronary infusion
Experimental: 2
Ad5FGF-4
Genetic: AdF5FGF-4 vs. Placebo
Intracoronary infusion
Placebo Comparator: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Cardium Therapeutics

Additional 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
Study First Received: September 10, 2005
Last Updated: November 4, 2008
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: Finnish Medicines Agency
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

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

ClinicalTrials.gov processed this record on September 30, 2014