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NCT01081145 · ClinicalTrials.gov registry record · Phase 3

Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)

A Phase 3 study, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
528
Enrollment target

NCT01081145 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 528 participants.

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The verdict

NCT01081145, a Phase 3 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
528 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.

Interventions

  • OTHER Placebo
  • DRUG Extended-release Guanfacine Hydrochloride

Trial Details

FieldValue
Enrollment Target 528 participants
Start Date 2010-05-11
Est. Completion 2013-06-03
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT01081145

The ClinicalTrials.gov registry entry for NCT01081145 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 528 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.

NCT01081145 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01081145 about?

NCT01081145 is a clinical study titled "Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)". The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.

What is the current status of trial NCT01081145?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 528 participants. The study started on 2010-05-11. Estimated completion is 2013-06-03.

What interventions are being tested in trial NCT01081145?

The interventions under investigation include: Placebo (OTHER), Extended-release Guanfacine Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT01081145?

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.