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NCT00117650 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients With Intermittent Claudication
A Phase 2 study of Atherosclerosis and Peripheral Vascular Disease, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 289
- Enrollment target
- 20
- Study locations
NCT00117650 is a Phase 2 study of Atherosclerosis and Peripheral Vascular Disease that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 289 participants, below the 1,061-participant average among 69 other Atherosclerosis trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT00117650, a Phase 2 study of Atherosclerosis and Peripheral Vascular Disease, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 289 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Ad2/HIF-1α/VP16
- OTHER Saline (Placebo Control)
Study Locations (20)
California
- VA Palo Alto Health Care System - Palo Alto
- University of California at Davis - Sacramento
- Stanford University School of Medicine - Stanford
Florida
- Palm Beach Heart Institute - Atlantis
- Baptist Health Care - Pensacola
- University of South Florida - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Medical Center - Boston
- Caritas St. Elizabeth's Medical Center, CCP4C - Boston
Illinois
- Rush University Medical Center - Chicago
- Prairie Cardiovascular Consultants, Ltd. - Springfield
Alabama
- Baptist Medical Center Princeton - Birmingham
Colorado
- University of Colorado Health Sciences Center - Denver
District of Columbia
- The Washington Hospital Center - Washington D.C.
Georgia
- Saint Joseph's Research Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2005-02 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00117650
The ClinicalTrials.gov registry entry for NCT00117650 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 289 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,061-participant average among 69 other Atherosclerosis trials with a reported enrollment target (73% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Atherosclerosis appearing as the primary indexed condition, and to 2 interventions - of which Ad2/HIF-1α/VP16 is the first listed.
NCT00117650 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00117650 about?
NCT00117650 is a clinical study titled "Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients With Intermittent Claudication". 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...
What is the current status of trial NCT00117650?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 289 participants. The study started on 2005-02. Estimated completion is 2010-03.
What conditions does trial NCT00117650 study?
This clinical trial studies the following conditions: Atherosclerosis, Peripheral Vascular Disease, Intermittent Claudication.
What interventions are being tested in trial NCT00117650?
The interventions under investigation include: Ad2/HIF-1α/VP16 (BIOLOGICAL), Saline (Placebo Control) (OTHER).
Who is sponsoring clinical trial NCT00117650?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00117650 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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