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CONCERTA Lab School Study

NCT00799487 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2020-03-12

Study results available
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Summary

The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

CONCERTA (methylphenidate HCl) or placebo

Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #1 with placebo on Day #2

DRUG

CONCERTA (methylphenidate HCl) or placebo

Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1

Sponsors & Collaborators

  • Ortho-McNeil Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial · Ortho-McNeil Janssen Scientific Affairs, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
9 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-02
Primary Completion
2009-06-26
Completion
2009-06-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00799487 on ClinicalTrials.gov