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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 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 528 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01081145
The ClinicalTrials.gov registry entry for NCT01081145 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 528 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01081145 reports 0 study locations.
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.
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