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NCT00566657 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 525
- Enrollment target
NCT00566657 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 525 participants.
The verdict
NCT00566657, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 525 participants
- Enrollment target
Study Summary
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions. Secondary objectives are to evaluate: * The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation; * The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death; * The safety of riferminogene pecaplasmid in the study population.
Interventions
- BIOLOGICAL riferminogene pecaplasmid
- BIOLOGICAL Placebo (for riferminogene pecaplasmid)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 525 participants |
| Start Date | 2007-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00566657
The ClinicalTrials.gov registry entry for NCT00566657 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 525 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 0 conditions, and to 2 interventions - of which riferminogene pecaplasmid is the first listed.
NCT00566657 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00566657 about?
NCT00566657 is a clinical study titled "Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions". Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions. Seco...
What is the current status of trial NCT00566657?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 525 participants. The study started on 2007-11. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00566657?
The interventions under investigation include: riferminogene pecaplasmid (BIOLOGICAL), Placebo (for riferminogene pecaplasmid) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00566657?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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