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NCT01081132 · ClinicalTrials.gov registry record · Phase 3
Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 314
- Enrollment target
NCT01081132: Completed Phase 3 study, sponsored by Shire.
NCT01081132 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 314 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01081132, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 314 participants
- Enrollment target
Study Summary
To assess the efficacy of optimized Extended-release Guanfacine Hydrochloride compared with placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured by the ADHD-RS-IV
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
- OTHER Placebo
- DRUG Extended-release Guanfacine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2011-09-19 |
| Est. Completion | 2013-05-16 |
| Phase | Phase 3 |
What the finished NCT01081132 record still lists
NCT01081132 is an interventional study that assigns participants to a tested intervention. The registered 314 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 (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01081132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01081132 about?
NCT01081132 is a clinical study titled "Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl". To assess the efficacy of optimized Extended-release Guanfacine Hydrochloride compared with placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured by the ADHD-RS-IV
What is the current status of trial NCT01081132?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2011-09-19. Estimated completion is 2013-05-16.
What interventions are being tested in trial NCT01081132?
The interventions under investigation include: Placebo (OTHER), Extended-release Guanfacine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01081132?
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 NCT01081132's enrollment target sits among peer trials
314 1096th of 2000 higher than 900 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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