Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088621
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2004-07-30
Brief Title:
A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
An Open-Label Multicenter Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia
Status:
COMPLETED
Status Verified Date:
2014-03
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:
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
Detailed Description:
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events AEs measures of extra pyramidal symptoms EPS Abnormal Involuntary Movement Scale AIMS Barnes Akathisia Scale BAS and Simpson-Angus Rating Scale SAS vital sign measurements electrocardiograms ECGs clinical laboratory evaluations
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