CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Methylphenidate HCl ER tablets 1 +3 moredrug
Likely dose
Not stated in 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/NCT02536105
NCT02536105N/ACompleted
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Pharmacokinetic Pharmacodynamic Studies of Methylphenidate Extended Release Products in Pediatric Attention Deficit Hyperactivity Disorder

Massachusetts General Hospital·interventional·Posted Aug 31, 2015·Updated Dec 10, 2019

In Brief

A clinical study evaluating Methylphenidate HCl ER tablets 1, Placebo, and 2 other interventions for Attention Deficit Hyperactivity Disorder. Completed, enrolled 88 participants across 2 sites.

Detailed Summary

The purpose of this study is to evaluate the association between blood drug levels and the corresponding scores of commonly used behavioral instruments based upon data collected following administration of three different methylphenidate hydrochloride extended-release drug products in children with ADHD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
CollaboratorsFood and Drug Administration (FDA), Center for Psychiatry And Behavioral Medicine Inc.

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 31, 2015
Enrollment StartMay 1, 2016
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.8 years ago

Interventions

Methylphenidate HCl ER tablets 1drug

Placebodrug

Methylphenidate HCl ER tablets 2drug

Methylphenidate HCl ER for suspensiondrug