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NCT00799487 · ClinicalTrials.gov registry record · Phase 4
CONCERTA Lab School Study
A Phase 4 study, sponsored by Ortho-McNeil Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 4
- Development phase
- 89
- Enrollment target
NCT00799487: Completed Phase 4 study, sponsored by Ortho-McNeil Janssen Scientific Affairs.
NCT00799487 is a Phase 4 study that has completed, run by Ortho-McNeil Janssen Scientific Affairs. The registered enrollment target is 89 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00799487, a Phase 4 study, has completed, sponsored by Ortho-McNeil Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 89 participants
- Enrollment target
Study Summary
The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.
Primary Outcome
PERMP (range: 0, 400) is a measure of academic productivity. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicativ
Interventions
- DRUG CONCERTA (methylphenidate HCl) or placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2009-01-02 |
| Est. Completion | 2009-06-26 |
| Phase | Phase 4 |
What the finished NCT00799487 record still lists
NCT00799487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which CONCERTA (methylphenidate HCl) or placebo is the first listed.
NCT00799487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00799487 about?
NCT00799487 is a clinical study titled "CONCERTA Lab School Study". The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.
What is the current status of trial NCT00799487?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 89 participants. The study started on 2009-01-02. Estimated completion is 2009-06-26.
What interventions are being tested in trial NCT00799487?
The interventions under investigation include: CONCERTA (methylphenidate HCl) or placebo (DRUG).
Who is sponsoring clinical trial NCT00799487?
This trial is sponsored by Ortho-McNeil Janssen Scientific Affairs, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00799487's enrollment target sits among peer trials
89 913th of 2000 higher than 1,085 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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