Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151970
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2005-09-07
Brief Title:
Efficacy Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD
Sponsor:
Noven Therapeutics
Organization:
Noven Therapeutics
Study Overview
Official Title:
A Phase IIB Randomized Double-blind Multi-Center Placebo-Controlled Dose-Optimization 3-way Cross-Over Analog Classroom Study to Assess the Efficacy Duration of Effect Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System MTS in Pediatric Subjects Aged 6-12 With Attention-DeficitHyperactivity Disorder ADHD
Status:
COMPLETED
Status Verified Date:
2015-07
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:
This study will assess the efficacy duration of effect tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD
Detailed Description:
Attention-DeficitHyperactivity Disorder ADHD is a psychiatric disorder characterized by 3 main symptoms inattention hyperactivity and impulsivity This study will assess the efficacy duration of effect tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD
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