Trials / Unknown
UnknownNCT00185263
Safety and Efficacy of Intracoronary Ad5FGF-4 in Patients With Stable Angina
A Multinational Multicenter, Randomized , Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Cardium Therapeutics · Industry
- Sex
- All
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | AdF5FGF-4 vs. Placebo | Intracoronary infusion |
Timeline
- Start date
- 2002-03-01
- Primary completion
- 2005-01-01
- Completion
- 2008-11-01
- First posted
- 2005-09-16
- Last updated
- 2008-11-06
Source: ClinicalTrials.gov record NCT00185263. Inclusion in this directory is not an endorsement.