Status:
COMPLETED
Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials
Lead Sponsor:
Sanofi
Conditions:
Peripheral Arterial Occlusive Disease
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to collect retrospectively long term safety data in patients who have participated in the previous phase I-II trials conducted with the compound.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patient randomized, treated and alive at the end of the phase I-II study participation, irrespective of their treatment group,
- Who signed the TALISMAN survey informed consent (or for deceased patients, the informed consent was signed the legal representative/family member as per national regulations - except in countries where Ethics Committee approval only is required for retrospective data collection).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT01135797
Start Date
June 1 2010
End Date
December 1 2010
Last Update
April 28 2011
Active Locations (7)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Diegem, Belgium
3
Sanofi-Aventis Administrative Office
Paris, France
4
Sanofi-Aventis Administrative Office
Berlin, Germany