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Aripiprazole Open-Label, Safety and Tolerability Study

NCT ID: NCT00102518

Last Updated: 2012-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-02-28

Brief Summary

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The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.

Detailed Description

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Conditions

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Schizophrenia Bipolar Disorder

Keywords

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Open Label Aripiprazole Bipolar I Disorder, Manic or Mixed Episode

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NCT00102063 and NCT00110461 Subjects

All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses

Interventions

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Aripiprazole

2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses

Intervention Type DRUG

Other Intervention Names

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OPC-14597

Eligibility Criteria

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Inclusion Criteria

* Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode

Exclusion Criteria

* Patients with a co-morbid serious, uncontrolled systemic illness
* Patients with a significant risk of committing suicide
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Local Institution

Birmingham, Alabama, United States

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Little Rock, Arkansas, United States

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Costa Mesa, California, United States

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Fresno, California, United States

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Orange, California, United States

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Riverside, California, United States

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Rosemead, California, United States

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Sacramento, California, United States

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Temecula, California, United States

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Washington D.C., District of Columbia, United States

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Altamonte Springs, Florida, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orange City, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Lake Charles, Louisiana, United States

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Metairie, Louisiana, United States

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New Orleans, Louisiana, United States

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Somerville, Massachusetts, United States

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Clinton, Michigan, United States

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Kansas City, Missouri, United States

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Saint Charles, Missouri, United States

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Elmsford, New York, United States

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New York, New York, United States

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Olean, New York, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Cleveland, Ohio, United States

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Lyndhurst, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Bala-Cynwyd, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Bellaire, Texas, United States

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DeSoto, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Wauwatosa, Wisconsin, United States

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Countries

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United States

Other Identifiers

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31-03-241

Identifier Type: -

Identifier Source: org_study_id