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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01135797 |
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Date of registration:
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01/06/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials
TALISMAN S |
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Scientific title:
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Retrospective Safety Survey In Patients Included In Phase I-II NV1FGF Clinical Trials |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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164 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01135797 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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Belgium
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France
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Germany
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Italy
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Sciences & Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Peripheral Arterial Occlusive Disease
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Primary Outcome(s)
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Incidence of Deaths
[Time Frame: From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake]
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Incidence of safety events of interest
[Time Frame: From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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