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NCT00507065 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 329
- Enrollment target
NCT00507065: Completed Phase 3 study, sponsored by Shire.
NCT00507065 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 329 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00507065, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 329 participants
- Enrollment target
Study Summary
Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (\<= 75 kg or \> 75 kg).
Interventions
- DRUG Placebo
- DRUG Mixed salts of a single-entity amphetamine (ADDERALL XR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 329 participants |
| Start Date | 2003-05-28 |
| Est. Completion | 2004-03-24 |
| Phase | Phase 3 |
What the finished NCT00507065 record still lists
NCT00507065 is an interventional study that assigns participants to a tested intervention. The registered 329 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 (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00507065 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00507065 about?
NCT00507065 is a clinical study titled "Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)". Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (\<= 75 kg or \> 75 kg).
What is the current status of trial NCT00507065?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 329 participants. The study started on 2003-05-28. Estimated completion is 2004-03-24.
What interventions are being tested in trial NCT00507065?
The interventions under investigation include: Placebo (DRUG), Mixed salts of a single-entity amphetamine (ADDERALL XR) (DRUG).
Who is sponsoring clinical trial NCT00507065?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00507065's enrollment target sits among peer trials
329 1074th of 2000 higher than 927 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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