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NCT00734578 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of SPD503 in Combination With Psychostimulants
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 461
- Enrollment target
NCT00734578: Completed Phase 3 study, sponsored by Shire.
NCT00734578 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 461 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00734578, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 461 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.
Primary Outcome
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 Placebo
- DRUG SPD503-AM
- DRUG SPD503-PM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 461 participants |
| Start Date | 2008-09-02 |
| Est. Completion | 2009-12-10 |
| Phase | Phase 3 |
What the finished NCT00734578 record still lists
NCT00734578 is an interventional study that assigns participants to a tested intervention. The registered 461 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 (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00734578 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00734578 about?
NCT00734578 is a clinical study titled "Efficacy and Safety of SPD503 in Combination With Psychostimulants". The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.
What is the current status of trial NCT00734578?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 461 participants. The study started on 2008-09-02. Estimated completion is 2009-12-10.
What interventions are being tested in trial NCT00734578?
The interventions under investigation include: Placebo (DRUG), SPD503-AM (DRUG), SPD503-PM (DRUG).
Who is sponsoring clinical trial NCT00734578?
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 NCT00734578's enrollment target sits among peer trials
461 822nd of 2000 higher than 1,178 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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