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NCT02493777 · ClinicalTrials.gov registry record · Phase 3
A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting
A Phase 3 study of Attention Deficit Hyperactivity Disorder, sponsored by Ironshore Pharmaceuticals and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 125
- Enrollment target
- 7
- Study locations
NCT02493777 is a Phase 3 study of Attention Deficit Hyperactivity Disorder that has completed, run by Ironshore Pharmaceuticals and Development. The registered enrollment target is 125 participants, below the 205-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (39% lower). The trial reports 7 study locations across 5 states.
The verdict
NCT02493777, a Phase 3 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Ironshore Pharmaceuticals and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 125 participants
- Enrollment target
- 7
- Study locations
Study Summary
This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week open-label treatment optimization period followed by a one week randomized, double-blind, placebo-controlled test phase.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG HLD200 methylphenidate hydrochloride (MPH) Capsules
Study Locations (7)
Florida
- Florida Clinical Research Center, LLC - Bradenton
- Florida Clinical Research Center, LLC - Maitland
Texas
- Bayou City Research, Ltd - Houston
- Westex Clinical Investigations - Lubbock
California
- AVIDA Inc. - Newport Beach
Massachusetts
- South Shore Psychiatric Services, PC - Marshfield
Nevada
- Center for Psychiatry and Behavioral Medicine, Inc. - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02493777
The ClinicalTrials.gov registry entry for NCT02493777 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (39% lower). The listed sponsor is Ironshore Pharmaceuticals and Development, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02493777 reports 7 study locations spanning 5 distinct geographic areas - top geographies include Florida, Texas, California.
Frequently Asked Questions
What is clinical trial NCT02493777 about?
NCT02493777 is a clinical study titled "A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting". This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week open-label treatment optimization period followed by a one week randomized, double-blind, placebo-controlled test ...
What is the current status of trial NCT02493777?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2015-07. Estimated completion is 2016-03.
What conditions does trial NCT02493777 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT02493777?
The interventions under investigation include: Placebo (DRUG), HLD200 methylphenidate hydrochloride (MPH) Capsules (DRUG).
Who is sponsoring clinical trial NCT02493777?
This trial is sponsored by Ironshore Pharmaceuticals and Development, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02493777 being conducted?
This trial has 7 study locations across California, Florida, Massachusetts, Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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