Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-29 @ 7:12 AM
Study NCT ID:
NCT00790192
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2008-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.
Sponsor:
Sumitomo Pharma America, Inc.
Organization:
Study Overview
Official Title:
A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)
Status:
COMPLETED
Status Verified Date:
2016-03
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:
PEARL 3
Brief Summary:
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: