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NCT01338818 · ClinicalTrials.gov registry record · Phase 3
Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 299
- Enrollment target
NCT01338818: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01338818 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 299 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01338818, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 299 participants
- Enrollment target
Study Summary
This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder
Primary Outcome
Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.
Interventions
- DRUG Ritalin LA (methylphenidate hydrochloride extended release)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
What the finished NCT01338818 record still lists
NCT01338818 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which Ritalin LA (methylphenidate hydrochloride extended release) is the first listed.
NCT01338818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01338818 about?
NCT01338818 is a clinical study titled "Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder". This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder
What is the current status of trial NCT01338818?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 299 participants. The study started on 2011-04. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01338818?
The interventions under investigation include: Ritalin LA (methylphenidate hydrochloride extended release) (DRUG).
Who is sponsoring clinical trial NCT01338818?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01338818's enrollment target sits among peer trials
299 1161st of 2000 higher than 839 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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