Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249353
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2005-11-04
Brief Title:
An Effectiveness and Safety Study of CONCERTA Methylphenidate Hydrochloride in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder
Sponsor:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Organization:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Study Overview
Official Title:
An Evaluation of the Safety and Effectiveness of CONCERTA Methylphenidate Hydrochloride up to 72 mg Daily in Adolescents With Attention Deficit Hyperactivity Disorder ADHD
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of CONCERTA methylphenidate hydrochloride a central nervous system CNS stimulant versus placebo for the treatment of Attention Deficit Hyperactivity Disorder ADHD in adolescents
Detailed Description:
The objective of this study is to evaluate the safety and effectiveness of CONCERTA methylphenidate hydrochloride in the treatment of adolescents with Attention Deficit Hyperactivity Disorder ADHD This is a multicenter randomized double-blind placebo-controlled study with adolescents ages 13-18 diagnosed with ADHD The study consists of four phases The Screening Phase establishes the diagnosis of ADHD and provides a one-week washout period without any ADHD medication The Open-Label Titration Phase initiates the treatment of patients with one CONCERTA 18 mg daily Thereafter the dose is increased approximately every 7 days in 18 mg increments to a maximum of 72 mg daily until an individualized dose is identified based on the clinical judgment of the investigator During the Double-Blind Phase subjects are randomized to receive either their individualized CONCERTA dose or a placebo for a period of 2 weeks Subjects who successfully complete the Double-Blind Phase are eligible to receive CONCERTA for an 8-week Open-Label Follow-up Phase The primary efficacy measurement is the total score of the ADHD Rating Scale evaluated by the investigator at the end of the Double-Blind Phase Safety assessments include monitoring adverse events electrocardiograms ECG blood pressure pulse height and weight throughout the course of the study The study hypothesis is that CONCERTA is more effective than placebo in the treatment of Attention Deficit Hyperactivity Disorder in adolescents and is well tolerated
Titration Phase CONCERTA 18 mg taken orally once daily and increased approximately every 7 days in 18 mg increments up to a maximum daily dose of 72 mg Double-Blind Phase Individualized dose of CONCERTA or placebo for 2 weeks Open-Label Phase Individualized dose of CONCERTA for 8 weeks
Titration Phase CONCERTA 18 mg taken orally once daily and increased approximately every 7 days in 18 mg increments up to a maximum daily dose of 72 mg Double-Blind Phase Individualized dose of CONCERTA or placebo for 2 weeks Open-Label Phase Individualized dose of CONCERTA for 8 weeks
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