Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250653
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2005-11-07
Brief Title:
A Fifty-two-week Study to Evaluate the Safety of Saredutant in Adult and Elderly Patients With Depression
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Fifty-two-week Multicenter Open-label Study Evaluating the Long-term Safety and Tolerability of Saredutant in Adult and Elderly Patients With Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the long-term safety of saredutant or SR48968C in adult and elderly patients with depressionThe primary objective is to evaluate the long-term safety and tolerability of a 100 mg dose of saredutant in adult and elderly patients with depression The secondary objective is to evaluate blood levels of saredutant
Detailed Description:
The study is a multicenter US open-label study consisting of two segments A and B Segment A is a minimum 1-week maximum 4-week screening period and Segment B is a 52-week open-label period All treated patients must complete a post-study telephone visit and a post-study office visit 3 days and 1 week respectively after intake of the last dose of study medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Saredutant SR48968C | None | None | None |