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NCT00185263 Clinical Trial

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

Stable Angina Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00185263
Other study ID # 305602
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received September 10, 2005
Last updated November 4, 2008
Start date March 2002
Est. completion date November 2008

Study information
Verified date November 2008
Source Cardium Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationArgentina: Human Research Bioethics CommitteeBelgium: Ministry of Social Affairs, Public Health and the EnvironmentCanada: Health CanadaFinland: Finnish Medicines AgencyIreland: Irish Medicines BoardUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 116
Est. completion date November 2008
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Genetic:
• AdF5FGF-4 vs. Placebo
Intracoronary infusion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cardium Therapeutics

Outcome
Type Measure Description Time frame Safety issue
Primary Treadmill exercise duration Week 12 No
Secondary Time to coronary events 1 Year No
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