Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT03580005
Status:
WITHDRAWN
Last Update Posted:
2018-11-01
First Post:
2018-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
Status:
WITHDRAWN
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was cancelled prior to the enrollment of any participants.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A 6-week double-blind study to evaluate the safety and efficacy of Quillichew extended release chewable tablets in 4-5 year old children with attention deficit hyperactivity disorder.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: