Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
Study NCT ID:
NCT00428792
Status:
COMPLETED
Last Update Posted:
2011-05-06
First Post:
2007-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
Sponsor:
Novartis
Organization:
Study Overview
Official Title:
An Open-label, Randomized, Rater-blinded, Cross-over, Multicenter Study Comparing the Clinical Efficacy of Methylphenidate (Immediate Release/Extended Release) Treatment (20 or 40 mg Orally od) in Children With Attention-Deficit Hyperactivity Disorder (ADHD) Under Different Breakfast Conditions Over Two Weeks
Status:
COMPLETED
Status Verified Date:
2011-04
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 study evaluated the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with Attention-Deficit Hyperactivity Disorder (ADHD).
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?: