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NCT00097266 · ClinicalTrials.gov registry record · Phase 3

Study of Aripiprazole in Patients With Acute Bipolar Mania

A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 3
Development phase
615
Enrollment target

NCT00097266 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 615 participants.

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The verdict

NCT00097266, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
615 participants
Enrollment target

Study Summary

The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.

Interventions

  • DRUG Placebo
  • DRUG Haloperidol
  • DRUG Aripiprazole

Trial Details

FieldValue
Enrollment Target 615 participants
Start Date 2004-12
Est. Completion 2007-01
Phase Phase 3

What the Registry Record Tells You About NCT00097266

The ClinicalTrials.gov registry entry for NCT00097266 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 615 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00097266 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00097266 about?

NCT00097266 is a clinical study titled "Study of Aripiprazole in Patients With Acute Bipolar Mania". The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.

What is the current status of trial NCT00097266?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 615 participants. The study started on 2004-12. Estimated completion is 2007-01.

What interventions are being tested in trial NCT00097266?

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

Who is sponsoring clinical trial NCT00097266?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

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

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.