Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190775
Status:
COMPLETED
Last Update Posted:
2011-08-22
First Post:
2005-09-12
Brief Title:
A Randomized Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-DeficitHyperactivity Disorder ADHD
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Randomized Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-DeficitHyperactivity Disorder With a Secondary Examination of Impact of Treatment on Family Functioning
Status:
COMPLETED
Status Verified Date:
2010-10
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 parallel design double-blind placebo-controlled multi-center 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder ADHD who are currently living in a family situation with at least one child The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 12 and 24 weeks of blinded treatment
Detailed Description:
The initial study was 34 weeks long however the protocol was amended to extend the open-label period of the study from 8 weeks to 12 weeks 38 weeks total
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 |
|---|---|---|---|
| B4Z-US-LYCW | OTHER | Eli Lilly and Company | None |