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An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder

This study has been completed.
Sponsor:
Information provided by:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
ClinicalTrials.gov Identifier:
NCT00249353
First received: November 4, 2005
Last updated: April 26, 2010
Last verified: April 2010

November 4, 2005
April 26, 2010
March 2002
Not Provided
Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
Same as current
Complete list of historical versions of study NCT00249353 on ClinicalTrials.gov Archive Site
Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale score, parent-evaluated weekly during Titration and Double-Blind Phases; Global Assessment of Effectiveness measured weekly during the Titration and Double-Blind Phases; Adverse events
Same as current
Not Provided
Not Provided
 
An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder
An Evaluation of the Safety and Effectiveness of CONCERTA® (Methylphenidate Hydrochloride), up to 72 mg Daily, in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

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..

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
Drug: methylphenidate hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
October 2002
Not Provided

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
13 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00249353
CR002668
Not Provided
Not Provided
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Not Provided
Study Director: McNeil Consumer & Specialty Pharmaceuticals Clinical Trial McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP