Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482612
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2007-06-01
Brief Title:
Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia P05706
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Two-Week Double Blind Placebo-Controlled Randomized Parallel Group Efficacy and Safety Out-Patient Trial With Org 50081 in Patients With Chronic Primary Insomnia
Status:
COMPLETED
Status Verified Date:
2018-09
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:
RUBY
Brief Summary:
The purpose of this study is to determine if esmirtazapine Org 50081 is a safe and effective treatment for insomnia It was anticipated that esmirtazapine would increase mean Total Sleep Time TST as recorded in sleep diaries relative to placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-8265-003 | OTHER | Protocol number | None |
| 176001 | OTHER | None | None |