Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients With Intermittent Claudication
Public ClinicalTrials.gov record NCT00117650. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-Selection Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 in Patients With Intermittent Claudication
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD). Specifically, this study will enroll patients with severe intermittent claudication (IC) which is the stage of PAD in which a patient's walking ability is severely limited, causing pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower limbs.
Study identification
- NCT ID
- NCT00117650
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 289 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2005 (Type not available)
- Primary completion
- Sep 2008 (Actual)
- Completion
- Mar 2010 (Actual)
- Last update posted
- Apr 3, 2015
2005 – 2010
United States locations
- U.S. sites
- 35
- U.S. states
- 21
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Baptist Medical Center Princeton | Birmingham | Alabama | 35211 | — |
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | — |
| University of California at Davis | Sacramento | California | 95817 | — |
| Stanford University School of Medicine | Stanford | California | 94305 | — |
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | — |
| The Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Palm Beach Heart Institute | Atlantis | Florida | 33462 | — |
| Baptist Health Care | Pensacola | Florida | 32522 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Saint Joseph's Research Institute | Atlanta | Georgia | 30342 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Prairie Cardiovascular Consultants, Ltd. | Springfield | Illinois | 32701 | — |
| The Care Group at the Heart Center | Indianapolis | Indiana | 46290 | — |
| Ochsner Clinic Foundation | Metairie | Louisiana | 70002 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Caritas St. Elizabeth's Medical Center, CCP4C | Boston | Massachusetts | 02135 | — |
| Henry Ford Hospital | Detroit | Michigan | 48126 | — |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55415 | — |
| Saint Louis University Hospital | St Louis | Missouri | 63104 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| New York University School of Medicine | New York | New York | 10003 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Jobst Vascular Center | Toledo | Ohio | 43606 | — |
| Medical University of Ohio | Toledo | Ohio | 43614 | — |
| University of Oklahoma, Health Sciences Center | Oklahoma City | Oklahoma | 73190 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Peripheral Vascular Associates | San Antonio | Texas | 78205 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00117650, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 3, 2015 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00117650 live on ClinicalTrials.gov.