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NCT01081145 · ClinicalTrials.gov registry record · Phase 3
Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 528
- Enrollment target
NCT01081145: Completed Phase 3 study, sponsored by Shire.
NCT01081145 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 528 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01081145, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 528 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.
Primary Outcome
Treatment failure was defined as \>= 50% increase (worsening) in ADHD-RS-IV total score and a \>= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment
Interventions
- OTHER Placebo
- DRUG Extended-release Guanfacine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 528 participants |
| Start Date | 2010-05-11 |
| Est. Completion | 2013-06-03 |
| Phase | Phase 3 |
What the finished NCT01081145 record still lists
NCT01081145 is an interventional study that assigns participants to a tested intervention. The registered 528 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 (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01081145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01081145 about?
NCT01081145 is a clinical study titled "Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)". The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.
What is the current status of trial NCT01081145?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 528 participants. The study started on 2010-05-11. Estimated completion is 2013-06-03.
What interventions are being tested in trial NCT01081145?
The interventions under investigation include: Placebo (OTHER), Extended-release Guanfacine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01081145?
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 NCT01081145's enrollment target sits among peer trials
528 711th of 2000 higher than 1,286 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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