Trials / Completed
CompletedNCT00346437
Efficacy and Safety of Intracoronary Ad5FGF-4 in Patients With Stable Angina (AGENT-3)
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 416 (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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Ad5FGF-4 vs. Placebo | Intracoronary infusion |
Timeline
- Start date
- 2001-10-01
- Primary completion
- 2005-01-01
- Completion
- 2008-11-01
- First posted
- 2006-06-30
- Last updated
- 2012-02-09
Source: ClinicalTrials.gov record NCT00346437. Inclusion in this directory is not an endorsement.