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NCT01244490 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 338
- Enrollment target
NCT01244490: Completed Phase 3 study, sponsored by Shire.
NCT01244490 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 338 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01244490, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 338 participants
- Enrollment target
Study Summary
For children and adolescents, how does SPD503 compare to placebo for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
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. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.
Interventions
- DRUG Placebo Comparator
- DRUG Atomoxetine Hydrochloride
- DRUG Extended-release Guanfacine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2011-01-17 |
| Est. Completion | 2013-05-01 |
| Phase | Phase 3 |
What the finished NCT01244490 record still lists
NCT01244490 is an interventional study that assigns participants to a tested intervention. The registered 338 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 (56% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo Comparator is the first listed.
NCT01244490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01244490 about?
NCT01244490 is a clinical study titled "Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)". For children and adolescents, how does SPD503 compare to placebo for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
What is the current status of trial NCT01244490?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 338 participants. The study started on 2011-01-17. Estimated completion is 2013-05-01.
What interventions are being tested in trial NCT01244490?
The interventions under investigation include: Placebo Comparator (DRUG), Atomoxetine Hydrochloride (DRUG), Extended-release Guanfacine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01244490?
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 NCT01244490's enrollment target sits among peer trials
338 1057th of 2000 higher than 942 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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