Trials / Unknown
UnknownNCT00438867
Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization
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
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Cardium Therapeutics · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Ad5FGF-4 | Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer |
| GENETIC | Placebo | Control group |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2009-11-01
- First posted
- 2007-02-22
- Last updated
- 2013-02-13
Locations
47 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00438867. Inclusion in this directory is not an endorsement.