|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Valentis |
|---|---|
| Information provided by: | Valentis |
| ClinicalTrials.gov Identifier: | NCT00068133 |
Purpose
The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared with placebo, administered bilaterally to the lower extremities, in subjects with intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT) for subjects receiving VLTS-589 compared with subjects receiving placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Intermittent Claudication Peripheral Vascular Disease |
Gene Transfer: Plasmid based Gene Transfer product-VLTS-589 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Multicenter, Double-Blind, Placebo-Controlled, Trial of VLTS-589 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease |
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Cardiology Pc | |
| Birmingham, Alabama, United States, 35211 | |
| United States, Arizona | |
| Arizona Heart Institute | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Access Clinical Trials-Cardiovascular Research | |
| Beverly Hills, California, United States, 90210 | |
| United States, Florida | |
| Heart Specialists of Sarasota Clinical Research Center | |
| Sarasota, Florida, United States, 34239 | |
| Jacksonville Heart Center | |
| Jacksonville, Florida, United States, 32207 | |
| United States, Georgia | |
| American Cardiovascular Research Institute | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Prairie Heart Institution at St. John's Hospital | |
| Springfield, Illinois, United States, 62701 | |
| Rush Presbyterian St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| The Care Group | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Louisiana | |
| New Orleans Center for Clinical Research | |
| New Orleans, Louisiana, United States, 70119 | |
| United States, Maine | |
| Androscoggin Cardiology Associates | |
| Auburn, Maine, United States, 04210 | |
| United States, Michigan | |
| University of Michigan Health Systems | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Minneapolis Heart Institution Foundation | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| St. Vincent's Hospital | |
| New York, New York, United States, 10011 | |
| United States, North Carolina | |
| Duke Clinical Research Institute | |
| Durham, North Carolina, United States, 27715 | |
| United States, Oklahoma | |
| University of Oklahoma Health Science Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Daniel Gottleib, MD | |
| Seattle, Washington, United States, 98166 | |
More Information
| Study ID Numbers: | VLTS-589-121 |
| Study First Received: | September 8, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00068133 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Arterial Occlusive Diseases Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases |
Intermittent Claudication Cardiovascular Diseases Arteriosclerosis |
