Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518986
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
2007-08-17
Brief Title:
Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep ApneaHypopnea and Depression
Sponsor:
Cephalon
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Associated With Obstructive Sleep ApneaHypopnea Syndrome With Major Depressive Disorder or Dysthymic Disorder
Status:
COMPLETED
Status Verified Date:
2013-07
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:
The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mgday is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apneahypopnea syndrome OSAHS who have comorbid major depressive disorder or dysthymic disorder
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