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NCT01101022 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 4 study, sponsored by Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 161
- Enrollment target
NCT01101022 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 161 participants.
The verdict
NCT01101022, a Phase 4 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 161 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score.
Interventions
- OTHER Placebo
- DRUG SPD489
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2010-05-19 |
| Est. Completion | 2010-11-29 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01101022
The ClinicalTrials.gov registry entry for NCT01101022 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 161 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.
NCT01101022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01101022 about?
NCT01101022 is a clinical study titled "Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)". The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report...
What is the current status of trial NCT01101022?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 161 participants. The study started on 2010-05-19. Estimated completion is 2010-11-29.
What interventions are being tested in trial NCT01101022?
The interventions under investigation include: Placebo (OTHER), SPD489 (DRUG).
Who is sponsoring clinical trial NCT01101022?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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