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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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
Interested in This Trial?
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, 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.
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