Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
Public ClinicalTrials.gov record NCT01239030. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01239030
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 230 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2010 (Type not available)
- Primary completion
- Feb 2012 (Actual)
- Completion
- Mar 2012 (Actual)
- Last update posted
- Feb 22, 2023
2010 – 2012
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Study Centers, LLC | Little Rock | Arkansas | 72205 | — |
| University of California, Irvine/Child Development Center | Irvine | California | 92612 | — |
| Synergy Research | National City | California | 91950 | — |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | — |
| Behavioral Clinical Research, Inc. | Lauderhill | Florida | 33319 | — |
| Martin Kane, DO | Maitland | Florida | 32751 | — |
| Segal Institute for clinical Research, North Miami Outpatient Clinic | North Miami | Florida | 33161 | — |
| South Shore Psychiatric Services, PC | Marshfield | Massachusetts | 02050 | — |
| Precise Research Center | Madison | Mississippi | 39110 | — |
| Center for Psychiatry and Behavioural Medicine Inc | Las Vegas | Nevada | 89128 | — |
| New York State Psychiatric Institute/Columbia University | New York | New York | 10032 | — |
| Department of Psychiatry, Duke University Medical Center | Durham | North Carolina | 27705 | — |
| CTMG | New Bern | North Carolina | 28562 | — |
| University of Cincinnati College of Medicine/PPSI | Cincinnati | Ohio | 45219 | — |
| University Hospital Case Medical Center | Cleveland | Ohio | 44106 | — |
| Wharton Research Center, Inc. | Wharton | Texas | 77488 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01239030, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 22, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01239030 live on ClinicalTrials.gov.