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| Sponsor: | Cardium Therapeutics |
|---|---|
| Information provided by: | Cardium Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00438867 |
Purpose
The purpose of this study is to determine whether a one-time intracoronary infusion of Ad5FGF-4 is effective in reducing the time to onset myocardial ischemia as measured by exercise treadmill testing and improving myocardial blood flow as measured by SPECT imaging. Exercise capacity, angina functional class, patient symptoms and quality of life will also be evaluated to characterize the efficacy of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Angina Pectoris |
Genetic: Ad5FGF-4 Genetic: Placebo |
Phase III |
| 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 Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Female Patients With Stable Angina Pectoris Who Are Not Candidates for Revascularization |
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2007 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Genetic: Ad5FGF-4
Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer
|
| Experimental: 2 |
Genetic: Ad5FGF-4
Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer
|
| Placebo Comparator: 3 |
Genetic: Placebo
Control group
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Can undergo ETT using the modified Bruce protocol and;
Exclusion Criteria:
Contacts and Locations
Show 47 Study Locations| Study Director: | Robert Engler, MD | Cardium Therapeutics |
More Information
| Responsible Party: | Robert Engler, MD / Chief Medical Advisor, Cardium Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00438867 History of Changes |
| Other Study ID Numbers: | CT-3-001 |
| Study First Received: | February 21, 2007 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
angina FGF-4 angiogenesis |
growth factor myocardia ischemia revascularization |
|
Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Signs and Symptoms |