Safety and Efficacy of Intracoronary Ad5FGF-4 in Patients With Stable Angina
Phase 2
- Conditions
- Stable Angina
- Interventions
- Genetic: AdF5FGF-4 vs. Placebo
- Registration Number
- NCT00185263
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 116
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 AdF5FGF-4 vs. Placebo Ad5FGF-4 3 AdF5FGF-4 vs. Placebo Placebo 1 AdF5FGF-4 vs. Placebo Ad5FGF-4
- Primary Outcome Measures
Name Time Method Treadmill exercise duration Week 12
- Secondary Outcome Measures
Name Time Method Time to coronary events 1 Year