Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 6:35 PM
Study NCT ID:
NCT00764660
Status:
TERMINATED
Last Update Posted:
2018-10-16
First Post:
2008-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
A Prospective, Double-Blind, Placebo-Controlled Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Subjects With Alcohol Dependence.
Status:
TERMINATED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on the outcome of a planned interim analysis, the study was stopped early due to futility.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OD-H
Brief Summary:
The purpose of this study is to assess the effects of SCH 900435 (Org 25935, MK-8435) on heavy drinking, safety and tolerability of SCH 900435 in participants with alcohol dependence.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: