Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01239030 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD

A Phase 3 study of Attention Deficit Hyperactivity Disorder and ADHD, sponsored by Rhodes Pharmaceuticals, L.P..

Completed
Registry status
Phase 3
Development phase
230
Enrollment target
16
Study locations

NCT01239030 is a Phase 3 study of Attention Deficit Hyperactivity Disorder and ADHD that has completed, run by Rhodes Pharmaceuticals, L.P.. The registered enrollment target is 230 participants, above the 204-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (13% higher). The trial reports 16 study locations across 10 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01239030, a Phase 3 study of Attention Deficit Hyperactivity Disorder and ADHD, has completed, sponsored by Rhodes Pharmaceuticals, L.P..

COMPLETED
Registry status
Phase 3
Development phase
230 participants
Enrollment target
16
Study locations

Study Summary

This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.

Interventions

  • DRUG Placebo
  • DRUG Methylphenidate Hydrochloride Extended Release Capsules

Study Locations (16)

Florida

  • Florida Clinical Research Center, LLC - Bradenton
  • Behavioral Clinical Research, Inc. - Lauderhill
  • Martin Kane, DO - Maitland
  • Segal Institute for clinical Research, North Miami Outpatient Clinic - North Miami

California

  • University of California, Irvine/Child Development Center - Irvine
  • Synergy Research - National City

North Carolina

  • Department of Psychiatry, Duke University Medical Center - Durham
  • CTMG - New Bern

Ohio

  • University of Cincinnati College of Medicine/PPSI - Cincinnati
  • University Hospital Case Medical Center - Cleveland

Arkansas

  • Clinical Study Centers, LLC - Little Rock

Massachusetts

  • South Shore Psychiatric Services, PC - Marshfield

Mississippi

  • Precise Research Center - Madison

Nevada

  • Center for Psychiatry and Behavioural Medicine Inc - Las Vegas

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2010-11
Est. Completion 2012-03
Phase Phase 3

Sponsor

Rhodes Pharmaceuticals, L.P.

10 total trials

What the Registry Record Tells You About NCT01239030

The ClinicalTrials.gov registry entry for NCT01239030 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 204-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (13% higher). The listed sponsor is Rhodes Pharmaceuticals, L.P., which has 10 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01239030 reports 16 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, North Carolina.

Frequently Asked Questions

What is clinical trial NCT01239030 about?

NCT01239030 is a clinical study titled "Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD". This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years o...

What is the current status of trial NCT01239030?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2010-11. Estimated completion is 2012-03.

What conditions does trial NCT01239030 study?

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

What interventions are being tested in trial NCT01239030?

The interventions under investigation include: Placebo (DRUG), Methylphenidate Hydrochloride Extended Release Capsules (DRUG).

Who is sponsoring clinical trial NCT01239030?

This trial is sponsored by Rhodes Pharmaceuticals, L.P., which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01239030 being conducted?

This trial has 16 study locations across Arkansas, California, Florida, Massachusetts, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Attention Deficit Hyperactivity Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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.