CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 725 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Ritalin LA 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/NCT01259492
NCT01259492Phase 3Completed
CompareCT.gov

A 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate HCl Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD

Novartis Pharmaceuticals·interventional·Posted Dec 14, 2010·Updated Oct 7, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo, Ritalin LA 20 mg, and 1 other intervention for Attention Deficit/Hyperactivity Disorder. Completed, enrolled 725 participants across 68 sites in 9 countries.

Detailed Summary

This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2010
Enrollment StartNov 1, 2010
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.5 years ago

Interventions

Placebodrug

Placebo Comparator: Placebo

Ritalin LA 20 mgdrug

Ritalin LA (a racemic mixture of d- and l-thre-Methylphenidate Hydrochloride (MPH), extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg.

Ritalin LA 30 mgdrug

Ritalin LA (a racemic mixture of d- and l-thre-Methylphenidate Hydrochloride (MPH), extended release hard capsules) taken orally once daily in doses of 60, or 80 mg.