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An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT01060150 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2013-08-23

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, tolerability and effects of Osmotic Release Oral System (OROS) methylphenidate hydrochloride (HCl) on learning skill changes in Korean participants with Attention-Deficit Hyperactivity Disorder (ADHD).

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

OROS Methylphenidate HCl

Osmotic Release Oral System (OROS) Methylphenidate HCl tablet will be given orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) of body weight and 27 mg for those more than or equal to 30 kg; the dose can be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg will be given orally once daily up to Week 12.

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea, Ltd. Clinical Trial · Janssen Korea, Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-04-30
Completion
2010-04-30

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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 NCT01060150 on ClinicalTrials.gov