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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: Completed Phase 2 study of Atherosclerosis and Peripheral Vascular Disease, sponsored by Genzyme, a Sanofi Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00117650 record still lists
NCT00117650 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, below the 1,061-participant average among 69 other Atherosclerosis trials with a reported enrollment target (73% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00117650's enrollment target sits among peer trials
289 28th of 69 higher than 42 of 69 other Atherosclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atherosclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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