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NCT01259492 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

A Phase 3 study of Attention Deficit/Hyperactivity Disorder, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
725
Enrollment target
20
Study locations

NCT01259492 is a Phase 3 study of Attention Deficit/Hyperactivity Disorder that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 725 participants, above the 244-participant average among 13 other Attention Deficit/Hyperactivity Disorder trials with a reported enrollment target (197% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT01259492, a Phase 3 study of Attention Deficit/Hyperactivity Disorder, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
725 participants
Enrollment target
20
Study locations

Study 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).

Interventions

  • DRUG Placebo
  • DRUG Ritalin LA 20 mg
  • DRUG Ritalin LA 30 mg

Study Locations (20)

Florida

  • Novartis Investigative Site - Bradenton
  • Novartis Investigative Site - Miami
  • Novartis Investigative Site - Orlando
  • Novartis Investigative Site - West Plam Beach

California

  • Novartis Investigative Site - Beverly Hills
  • Novartis Investigative Site - Spring Valley

Nevada

  • Novartis Investigative Site - Las Vegas
  • Novartis Investigative Site - Las Vegas

Texas

  • Novartis Investigative Site - Houston
  • Novartis Investigative Site - Houston

Arkansas

  • Novartis Investigative Site - Little Rock

Illinois

  • Novartis Investigative Site - Libertyville

Kentucky

  • Novartis Investigative Site - Owensboro

Michigan

  • Novartis Investigative Site - Troy

Trial Details

FieldValue
Enrollment Target 725 participants
Start Date 2010-11
Est. Completion 2012-08
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01259492

The ClinicalTrials.gov registry entry for NCT01259492 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 725 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 244-participant average among 13 other Attention Deficit/Hyperactivity Disorder trials with a reported enrollment target (197% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Attention Deficit/Hyperactivity Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01259492 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, California, Nevada.

Frequently Asked Questions

What is clinical trial NCT01259492 about?

NCT01259492 is a clinical study titled "Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)". 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).

What is the current status of trial NCT01259492?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 725 participants. The study started on 2010-11. Estimated completion is 2012-08.

What conditions does trial NCT01259492 study?

This clinical trial studies the following conditions: Attention Deficit/Hyperactivity Disorder.

What interventions are being tested in trial NCT01259492?

The interventions under investigation include: Placebo (DRUG), Ritalin LA 20 mg (DRUG), Ritalin LA 30 mg (DRUG).

Who is sponsoring clinical trial NCT01259492?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01259492 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.