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Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization

NCT00438867 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-02-13

No results posted yet for this study

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

  • Angina Pectoris

Interventions

GENETIC

Ad5FGF-4

Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer

GENETIC

Placebo

Control group

Sponsors & Collaborators

  • Cardium Therapeutics

    lead INDUSTRY

Principal Investigators

  • Robert Engler, MD · Cardium Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00438867 on ClinicalTrials.gov