Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT00152035
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of SPD465 in Treating Adults With ADHD.
Sponsor:
Shire
Organization:
Study Overview
Official Title:
A Phase III, Multi-center, 12-month, Open-label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
Status:
COMPLETED
Status Verified Date:
2021-08
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 purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: