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Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.

NCT00776009 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2011-06-08

Study results available
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Summary

This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.

Conditions

  • Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions

DRUG

Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)

10 mg and/or 20 mg capsules

DRUG

Placebo

Placebo Comparator

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT00776009 on ClinicalTrials.gov