Status:
COMPLETED
Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease
Lead Sponsor:
Sanofi
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD). A secondary objective...
Detailed Description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
Eligibility Criteria
Inclusion
- Patients who have participated in Study EFC5286 and completed the study.
- Patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures specifically for this LTS5283 extension.
Exclusion
- Females who are pregnant or breast-feeding.
- Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit,and must use an acceptable method of birth control.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00285077
Start Date
March 1 2004
End Date
November 1 2006
Last Update
December 23 2008
Active Locations (7)
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1
Sanofi-Aventis Administrative Office
Laval, Canada
2
Sanofi-Aventis Administrative Office
Horslholm, Denmark
3
Sanofi-Aventis Administrative Office
Helsinki, Finland
4
Sanofi-Aventis Administrative Office
Paris, France