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NCT00337285 · ClinicalTrials.gov registry record · Phase 3
An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study, sponsored by New River Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 349
- Enrollment target
NCT00337285: Completed Phase 3 study, sponsored by New River Pharmaceuticals.
NCT00337285 is a Phase 3 study that has completed, run by New River Pharmaceuticals. The registered enrollment target is 349 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00337285, a Phase 3 study, has completed, sponsored by New River Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 349 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the long-term safety and efficacy of three NRP104 doses of 30 mg, 50 mg, or 70 mg, administered at the same time daily, in the treatment of adults with ADHD.
Primary Outcome
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Interventions
- DRUG Vyvanse (lisdexamfetamine dimesylate), NRP104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 349 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
What the finished NCT00337285 record still lists
NCT00337285 is an interventional study that assigns participants to a tested intervention. The registered 349 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 (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Vyvanse (lisdexamfetamine dimesylate), NRP104 is the first listed.
NCT00337285 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00337285 about?
NCT00337285 is a clinical study titled "An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)". The purpose of this study is to assess the long-term safety and efficacy of three NRP104 doses of 30 mg, 50 mg, or 70 mg, administered at the same time daily, in the treatment of adults with ADHD.
What is the current status of trial NCT00337285?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 349 participants. The study started on 2006-07. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00337285?
The interventions under investigation include: Vyvanse (lisdexamfetamine dimesylate), NRP104 (DRUG).
Who is sponsoring clinical trial NCT00337285?
This trial is sponsored by New River Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00337285's enrollment target sits among peer trials
349 1045th of 2000 higher than 956 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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