Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01903837
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2013-07-05
Brief Title:
A Study of ALKS 3831 in Adults With Schizophrenia
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
A Phase 2 Randomized Multicenter Safety Tolerability and Dose-Ranging Study of Samidorphan a Component of ALKS 3831 in Adults With Schizophrenia Treated With Olanzapine
Status:
COMPLETED
Status Verified Date:
2021-09
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:
This is a Phase 2 randomized placebo-controlled multicenter study which will be conducted in 2 parts The study duration for each subject will be approximately 33 weeks and will include 25 study visits
Detailed Description:
None
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