A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting
Public ClinicalTrials.gov record NCT02493777. 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
Ph 3 Multicenter OL Treatment-optimized RDBPC Forced-withdrawal, Parallel Grp Study to Evaluate Safety & Efficacy of Evening Dosed HLD200, a Novel DR/ER Formulation (DELEXIS) of MPH HCl in Children Aged 6-12 With ADHD in Classroom Setting
Study identification
- NCT ID
- NCT02493777
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Ironshore Pharmaceuticals and Development, Inc
- Other
- Enrollment
- 125 participants
Conditions and interventions
Conditions
Interventions
- HLD200 methylphenidate hydrochloride (MPH) Capsules Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years to 12 Years
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2015
- Primary completion
- Jan 31, 2016
- Completion
- Feb 29, 2016
- Last update posted
- Jul 22, 2021
2015 – 2016
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AVIDA Inc. | Newport Beach | California | 92660 | — |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | — |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | — |
| South Shore Psychiatric Services, PC | Marshfield | Massachusetts | 02050 | — |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | — |
| Bayou City Research, Ltd | Houston | Texas | 77007 | — |
| Westex Clinical Investigations | Lubbock | Texas | 79423 | — |
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 NCT02493777, 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 Jul 22, 2021 · Synced Apr 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02493777 live on ClinicalTrials.gov.