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NCT01106430 · ClinicalTrials.gov registry record · Phase 3

Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

A Phase 3 study, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
267
Enrollment target

NCT01106430 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 267 participants.

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The verdict

NCT01106430, a Phase 3 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
267 participants
Enrollment target

Study Summary

This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.

Interventions

  • DRUG Lisdexamfetamine Dimesylate
  • DRUG Atomoxetine Hydrochloride

Trial Details

FieldValue
Enrollment Target 267 participants
Start Date 2010-06-28
Est. Completion 2012-07-19
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT01106430

The ClinicalTrials.gov registry entry for NCT01106430 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 267 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 Lisdexamfetamine Dimesylate is the first listed.

NCT01106430 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01106430 about?

NCT01106430 is a clinical study titled "Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate". This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.

What is the current status of trial NCT01106430?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 267 participants. The study started on 2010-06-28. Estimated completion is 2012-07-19.

What interventions are being tested in trial NCT01106430?

The interventions under investigation include: Lisdexamfetamine Dimesylate (DRUG), Atomoxetine Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT01106430?

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.