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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.

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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

FieldValue
Enrollment Target 161 participants
Start Date 2010-05-19
Est. Completion 2010-11-29
Phase Phase 4

Sponsor

Shire

245 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.