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Sponsored by: |
Cardium Therapeutics |
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Information provided by: | Cardium Therapeutics |
ClinicalTrials.gov Identifier: | NCT00346437 |
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. Two doses will be studied, 2.87 x 10(8) and 2.87 x 10(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 |
---|---|---|
Angina Pectoris |
Genetic: Ad5FGF-4 vs. Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina |
Enrollment: | 416 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | November 2008 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Ad5FGF-4
|
Genetic: Ad5FGF-4 vs. Placebo
Intracoronary infusion
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2: Experimental
Ad5FGF-4
|
Genetic: Ad5FGF-4 vs. Placebo
Intracoronary infusion
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3: Placebo Comparator
Placebo
|
Genetic: Ad5FGF-4 vs. Placebo
Intracoronary infusion
|
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cardium Therapeutics ( Chief Medical Officer ) |
Study ID Numbers: | 304386 |
Study First Received: | June 28, 2006 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00346437 |
Health Authority: | United States: Food and Drug Administration |
angina FGF-4 angiogenesis adenovector |
growth factor myocardial ischemia revascularization |
Signs and Symptoms Heart Diseases Myocardial Ischemia Vascular Diseases |
Angina Pectoris Pain Ischemia Chest Pain |
Cardiovascular Diseases |