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NCT00500149 · ClinicalTrials.gov registry record · Phase 3

A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)

A Phase 3 study, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
129
Enrollment target

NCT00500149 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 129 participants.

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The verdict

NCT00500149, a Phase 3 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
129 participants
Enrollment target

Study Summary

The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

Interventions

  • DRUG Placebo
  • DRUG Vyvanse (lisdexamfetamine dimesylate)

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2007-06-13
Est. Completion 2007-12-05
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00500149

The ClinicalTrials.gov registry entry for NCT00500149 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 129 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.

NCT00500149 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00500149 about?

NCT00500149 is a clinical study titled "A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)". The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

What is the current status of trial NCT00500149?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2007-06-13. Estimated completion is 2007-12-05.

What interventions are being tested in trial NCT00500149?

The interventions under investigation include: Placebo (DRUG), Vyvanse (lisdexamfetamine dimesylate) (DRUG).

Who is sponsoring clinical trial NCT00500149?

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.