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

COMPLETED Phase 3

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

NCT01239030 · View on ClinicalTrials.gov ↗

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.

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01239030

The ClinicalTrials.gov registry entry for NCT01239030 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhodes Pharmaceuticals, L.P., which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01239030 reports 16 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01239030?

The interventions under investigation include: Placebo (DRUG), Methylphenidate Hydrochloride Extended Release Capsules (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01239030?

This trial is sponsored by Rhodes Pharmaceuticals, L.P., which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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