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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: Completed Phase 3 study of Attention Deficit Hyperactivity Disorder and ADHD, sponsored by Rhodes Pharmaceuticals, L.P..
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, roughly in line with the 214-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target. The trial reports 16 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in ADHD-RS-IV Total Score from Baseline (Visit 2) to end of Double Blind Phase (Visit 3); \[Calculations of baseline values (Visit 2) minus end of Double Blind values (Visit 3), higher differences means better outcomes\]. Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): The home version of the ADHD-RS-IV comprising symptoms of ADHD was used. This 18-item scale incorporates each of the ADHD symptoms regardless of assigned subtype. Trained clinicians administered ques
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 |
What the finished NCT01239030 record still lists
NCT01239030 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 214-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target.
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 lists 16 locations in 10 states (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.
Learn More About Clinical Trials
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Where NCT01239030's enrollment target sits among peer trials
230 28th of 102 higher than 75 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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