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NCT00367835 · ClinicalTrials.gov registry record · Phase 3
SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 217
- Enrollment target
NCT00367835: Completed Phase 3 study, sponsored by Shire.
NCT00367835 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 217 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00367835, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 217 participants
- Enrollment target
Study Summary
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
Primary Outcome
The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.
Interventions
- DRUG Placebo
- DRUG SPD503 (Guanfacine hydrochloride)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2006-12-04 |
| Est. Completion | 2008-01-04 |
| Phase | Phase 3 |
What the finished NCT00367835 record still lists
NCT00367835 is an interventional study that assigns participants to a tested intervention. The registered 217 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 (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00367835 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00367835 about?
NCT00367835 is a clinical study titled "SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms". To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
What is the current status of trial NCT00367835?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 217 participants. The study started on 2006-12-04. Estimated completion is 2008-01-04.
What interventions are being tested in trial NCT00367835?
The interventions under investigation include: Placebo (DRUG), SPD503 (Guanfacine hydrochloride) (DRUG).
Who is sponsoring clinical trial NCT00367835?
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 NCT00367835's enrollment target sits among peer trials
217 1332nd of 2000 higher than 669 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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