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NCT01227668 · ClinicalTrials.gov registry record · Phase 4

Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder

A Phase 4 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 4
Development phase
215
Enrollment target

NCT01227668 is a Phase 4 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 215 participants.

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The verdict

NCT01227668, a Phase 4 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 4
Development phase
215 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo

Interventions

  • DRUG Placebo
  • DRUG Aripiprazole

Trial Details

FieldValue
Enrollment Target 215 participants
Start Date 2011-03
Est. Completion 2012-06
Phase Phase 4

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT01227668

The ClinicalTrials.gov registry entry for NCT01227668 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01227668 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01227668 about?

NCT01227668 is a clinical study titled "Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder". The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo

What is the current status of trial NCT01227668?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 215 participants. The study started on 2011-03. Estimated completion is 2012-06.

What interventions are being tested in trial NCT01227668?

The interventions under investigation include: Placebo (DRUG), Aripiprazole (DRUG).

Who is sponsoring clinical trial NCT01227668?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 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.