Status:
COMPLETED
An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder
Lead Sponsor:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
13-18 years
Phase:
PHASE3
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 Attenti...
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...
Eligibility Criteria
Inclusion
- Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Children's Global Assessment Scale rating of 41-70 at baseline (Screening Phase)
Exclusion
- Subjects who are known to not respond to methylphenidate
- Have had adverse experiences from methylphenidate or hypersensitivity to CONCERTA or its components
- Have marked anxiety, tension or agitation
- Have glaucoma, ongoing seizure disorder, psychotic disorder, Tourette's disorder or family history of Tourette's disorder
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2002
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00249353
Start Date
March 1 2002
End Date
October 1 2002
Last Update
April 28 2010
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