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NCT00798005 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.
A Phase 2 study of Severe Peripheral Artery Occlusive Disease, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT00798005 is a Phase 2 study of Severe Peripheral Artery Occlusive Disease that has completed, run by Sanofi. The registered enrollment target is 71 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00798005, a Phase 2 study of Severe Peripheral Artery Occlusive Disease, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
Study Summary
Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes lifelong disablement from a painful leg. The clinical consequences of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in the distal limbs.A variety of medical therapies have been investigated for patients with PAOD. There is currently no evidence to suggest that any medical therapy is effective for patients with rest pain and/or ischemic ulcers. Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a improvement in clinical and hemodynamic status in patients with severe PAOD
Conditions Studied
Interventions
- DRUG XRP0038 (NV1FGF)
Study Locations (1)
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2002-06 |
| Est. Completion | 2005-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00798005
The ClinicalTrials.gov registry entry for NCT00798005 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Severe Peripheral Artery Occlusive Disease appearing as the primary indexed condition, and to 1 intervention - of which XRP0038 (NV1FGF) is the first listed.
NCT00798005 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT00798005 about?
NCT00798005 is a clinical study titled "Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.". Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes l...
What is the current status of trial NCT00798005?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2002-06. Estimated completion is 2005-07.
What conditions does trial NCT00798005 study?
This clinical trial studies the following conditions: Severe Peripheral Artery Occlusive Disease.
What interventions are being tested in trial NCT00798005?
The interventions under investigation include: XRP0038 (NV1FGF) (DRUG).
Who is sponsoring clinical trial NCT00798005?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00798005 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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