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| Sponsored by: |
Sanofi-Aventis |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00566657 |
Purpose
The primary objective of the study is to demonstrate the superiority of 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.
The secondary objectives of the study are to evaluate:
| Condition | Intervention | Phase |
|
Peripheral Vascular Diseases |
Drug: XRP0038/NV1FGF |
Phase III |
| MedlinePlus related topics: | Peripheral Vascular Diseases Vascular Diseases |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions |
Eligibility
| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations| Contact: Public Registry ICD | GV-Contact-us@sanofi-aventis.com |
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Show 30 Study Locations |
| Sanofi-Aventis |
More Information
Related Info 
  |
| Responsible Party: | sanofi-aventis ( ICD ) |
| Study ID Numbers: | EFC6145, XRP0038, EudraCT 2006-006277-24 |
| First Received: | November 30, 2007 |
| Last Updated: | March 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00566657 |
| Health Authority: | United States: Food and Drug Administration; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Russia: Ministry of Health and Social Development of the Russian Federation |
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