CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 299 enrolled
Drug / intervention
Ritalin LA (methylphenidate hydrochloride extended release)drug
Likely dose
Ritalin LA (methylphenidate hydrochloride extended release) 20 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/NCT01338818
NCT01338818Phase 3Completed
CompareCT.gov

A 6-month, Open-label Extension to a 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD

Novartis Pharmaceuticals·interventional·Posted Apr 20, 2011·Updated Nov 24, 2014

In Brief

A Phase 3 clinical trial evaluating Ritalin LA (methylphenidate hydrochloride extended release) for Attention Deficit/Hyperactivity Disorder. Completed, enrolled 299 participants across 48 sites in 6 countries.

Detailed Summary

This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit/Hyperactivity Disorder
CountriesBelgium, Colombia, Denmark, Germany, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2011
Enrollment StartApr 1, 2011
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.2 years ago

Interventions

Ritalin LA (methylphenidate hydrochloride extended release)drug

Ritalin LA 20 mg or 30 mg (a racemic mixture of d- and l-thre-Methylphenidate Hydrocloride (MPH), Extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg. For 40mg dose patients took (2) Ritalin LA 20mg daily, for 60mg patients took (2) Ritalin LA 30mg daily and for 80mg patients took (2) Ritalin LA 30mg daily + (1) Ritalin LA 20mg daily for their optimal dose.