CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 78 enrolled
Drug / intervention
Placebo/ CONCERTA (methylphenidate HCl) +1 moredrug
Likely dose
Placebo/ CONCERTA (methylphenidate HCl) 18 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00799409
NCT00799409Phase 4Completed
CompareCT.gov

The ABC Study: A Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral, and Cognitive Effects of CONCERTA on Older Children With ADHD

Ortho-McNeil Janssen Scientific Affairs, LLC·interventional·Posted Nov 27, 2008·Updated May 9, 2014

In Brief

A Phase 4 clinical trial evaluating Placebo/ CONCERTA (methylphenidate HCl) and CONCERTA (methylphenidate HCl) / Placebo for Attention Deficit Hyperactivity Disorder. Completed, enrolled 78 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 27, 2008
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.6 years ago

Interventions

Placebo/ CONCERTA (methylphenidate HCl)drug

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

CONCERTA (methylphenidate HCl) / Placebodrug

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