CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Methylphenidate HCl ER Capsules, 10 mg +2 moredrug
Likely dose
Methylphenidate HCl ER Capsules, 10 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/NCT02470234
NCT02470234Phase 4Completed
CompareCT.gov

A Pharmacokinetic Study of Aptensio XR® (Methylphenidate Hydrochloride (HCl) Extended-release) Capsules in Male or Female Pre-School Children 4 to Under 6 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD) in Fed Condition

Rhodes Pharmaceuticals, L.P.·interventional·Posted Jun 12, 2015·Updated Nov 24, 2021

In Brief

A Phase 4 clinical trial evaluating Methylphenidate HCl ER Capsules, 10 mg, Methylphenidate HCl ER Capsules, 15 mg, and 1 other intervention for Attention-Deficit/Hyperactivity Disorder. Completed, enrolled 10 participants across 2 sites.

Detailed Summary

To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules under fed conditions in male or female children 4 to under 6 years of age with ADHD.

Study Details

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

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 12, 2015
Enrollment StartJul 30, 2016
Primary CompletionJul 20, 2017
Study CompletionAug 7, 2017
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 11.1 years ago

Interventions

Methylphenidate HCl ER Capsules, 10 mgdrug

Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg administered once daily in the morning

Methylphenidate HCl ER Capsules, 15 mgdrug

Methylphenidate Hydrochloride Extended-Release Capsules, 15 mg administered once daily in the morning

Methylphenidate HCl ER Capsules, 20 mgdrug

Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg administered once daily in the morning